Certification & Compliance
This page sets out how our thread products are certified, how they are labelled, and how a buyer can check both. It also lists the questions we think any thread supplier should be able to answer, with our own answers given alongside.
Supplier pages in this industry tend to make the same three claims: certified, high quality, trusted. None of those claims can be checked, which is why they carry very little weight with buyers. Everything on this page is written so that it can be verified, either against a document we can send you or against the goods in your hand.
The checks in sections 1, 2 and 10 can be applied to any supplier, not only to us. Section 2 lists seven questions that are worth asking before an order is placed.
1. How to read a thread label
A sterile thread pouch carries more information than most people read off it. Each marking on the pouch exists so that a single unit can be traced back to a production run that a manufacturer is prepared to answer for. The table below lists what appears on our labels and what each item allows a buyer to check.
| Marking on the pouch | What it tells you | What can be checked with it |
|---|---|---|
| Gauge and length | The needle size and thread length of this unit | That the specification supplied matches the specification ordered |
| Product code | The thread type and configuration, for example a 4D cog | That the thread type matches the order and the intended treatment |
| Manufacturing date | When the batch was produced | How much of the shelf life has been received rather than consumed in storage |
| Batch number | Which production run this unit belongs to | Whether the supplier can trace this unit and answer questions about it |
| Expiry date | The last date on which the batch may be used | That no expired stock is held in inventory |
| CE mark | That the product has been assessed against the European requirements applying to a device of this class | That a certificate exists and can be requested, rather than a claim taken on trust |
| STERILE | EO · single use | Sterilised with ethylene oxide, for one use only | That re-sterilisation and reuse are excluded for anyone handling the product |
A pouch carrying all of these markings can be traced back through the supply chain. A pouch carrying only a brand name offers nothing to trace it with.
2. Seven questions to ask any thread supplier, including us
These are the questions we would put to a supplier before ordering from them, and the ones we expect to be asked ourselves. They can be sent in a single email.
-
Can you send me the CE certificate for the products I am ordering?
A CE mark printed on a pouch is a claim. The certificate is the document behind it, and it is the version that can be kept on file and shown to a regulator or a hospital buyer. -
What exactly does the certificate cover, and is the specific product I am ordering on it?
Certificates have scopes. One that covers a thread family may not cover every gauge and size within that family. -
Can you show me the batch record for the units you are about to ship me?
This distinguishes a certified company from a traceable box. Only the second is of use if a patient raises a question nine months later. -
Are the threads supplied sterile, and by what method?
The answer determines how the product must be stored and whether it can be relied on as delivered. -
What expiry date is printed on the units you are shipping me right now?
A two-year shelf life is of limited value if the stock supplied was produced eighteen months ago. The answer also indicates whether stock rotation is being managed at all. -
Where does the raw material come from, and can you document it?
The thread is the device. The polymer it is extruded from is where quality begins, and it is the part most suppliers are unable to produce documentation for. -
If something goes wrong in use, who do I contact, and what paperwork will I be given?
This information is easier to provide before a problem exists than after one does.
Our answers to each of these follow, in order.
3. Questions 1 and 2: our CE certification
All Firmosa thread products are CE marked. The CE mark is printed on the sterile pouch of every unit we ship.
CE marking is the manufacturer's declaration that a product meets the European requirements that apply to it. For a device of this kind, the mark does not rest on the manufacturer's word alone. The product is assessed before the mark is applied, and the outcome of that assessment is documented. Two documents therefore sit behind the mark: our own declaration of conformity, and the certificate issued following the conformity assessment.
The certificate is available on request, and we send the actual document rather than a summary or a photograph of a front page. Tell us which product line you are ordering and we will confirm whether it falls inside the scope of what we send you. If it falls outside that scope, we will say so, because a certificate that does not cover your product is of no use to you. Write to sherry@fillertop.com; we reply within 24 hours on business days.
One note on placement, since it is useful when a box is opened. Under the rules, the CE mark is affixed to the device or to its sterile packaging, and it also appears in the instructions for use and on the sales packaging. The pouch is the layer that travels with the product itself, so it is the first place to look.
4. Question 3: tracing a batch
Every unit we ship is individually labelled and traceable. Each thread carries a label printed with the gauge and length, the product code, the manufacturing date, the batch number and the expiry date.
The practical effect is straightforward. If a customer asks six months from now which batch was used in a treatment, the number can be read off the pouch and we can identify the production run. Where no batch number exists, there is no way to answer that question at all.
If batch information is required for your market's registration or import paperwork, ask us and we will confirm what can be provided for your order. We would rather state what is available than promise a document that cannot be issued.
5. Question 4: sterility, and how the packaging protects it
Threads are sterile, single-use devices. The following is printed on the product itself, so it can be checked on the goods in your hand rather than taken on trust:
- Sterilised by EO gas (ethylene oxide)
- Non-toxic and non-pyrogenic
- Heavy metal free
- Single use only — do not re-sterilise and do not reuse
- CE marked
Each thread is supplied in an individual sterile pouch, and the pouches are packed in an aluminium foil outer bag. The outer bag serves a purpose rather than being decorative. Moisture and light degrade a PDO thread before it ever reaches a patient, and the foil barrier is what keeps the shelf life printed on the label valid through transport and through storage.
The seal matters for the same reason. A pouch that has lifted, been resealed, or carries adhesive residue no longer provides the guarantee that counts, and it should not be used. See section 10 for what to check on arrival.
6. Question 5: how much shelf life you receive
Our threads carry a shelf life of 2 years from the manufacturing date. The expiry date is printed on each label.
The figure that affects a buyer is the shelf life remaining on the day the box arrives, not the total shelf life on the specification. A supplier can offer a two-year product and still ship stock carrying four months. Both statements may be true of the same shipment.
Check the manufacturing date on the first pouch opened against the date the order arrived. If what we send leaves you with less working time than you need, contact us before the batch is used and we will resolve it.
7. Question 6: raw material and what we do not claim
Firmosa is a Korean brand. Our PDO threads, PCL threads, PLLA threads and HA filler all carry the Firmosa name, and our raw materials are sourced from Korea. Korean aesthetics is our field, and it is the standard we build to.
The wording here is deliberate rather than casual. "Korean brand" and "raw material sourced from Korea" are statements about our own identity and our own supply chain, and we are the right party to make them. A statement about where a device was manufactured is a different class of claim, requiring production documentation for a specific site, and we do not assert it on a web page.
Where a market requires documentation on origin, tell us what your authority asks for and we will confirm what can be supplied.
8. Question 7: if something goes wrong
Contact us at sherry@fillertop.com with the batch number from the pouch. Send it even if it is not yet clear that there is a problem; it allows us to look at the actual production run rather than estimate.
We will check the batch against our record for your order, report what we find, and confirm what can be provided. Where the issue concerns the goods as delivered, such as a damaged pouch, a specification that does not match the order, or a missing item, it is handled under our Refund & Returns Policy, which has a faster path for these cases. Contact us within 7 days of delivery with your order number, a short description and photographs.
Questions about technique, indications or patient selection are clinical matters for the treating practitioner. We will say so rather than treat a clinical question as a shipping question.
9. What CE is not
Most confusion about certification in this industry arises from treating one mark as though it were several. The table below sets out the readings we see most often, and what the mark actually means.
| CE is sometimes read as… | What it actually means |
|---|---|
| "Approved worldwide" | CE marking is a European assessment. Every other market runs its own approval system, applied for separately and granted separately, and we do not claim any market's clearance that we do not hold. |
| "Approved in every country" | The same point stated differently. A European certificate has no legal effect in a market that requires its own registration, and buyers in those markets will need separate documents. |
| "The factory is certified" | A certificate covers a product and its scope. Whether a particular manufacturing site holds any further management-system certification is a separate question, and we do not claim one. |
| "Guaranteed safe and effective" | A conformity assessment is not a guarantee of outcome. Results depend on the patient, the indication and the technique of the practitioner. |
10. How to inspect a delivery when it arrives
This takes about three minutes per order, and it is the part of the process that is entirely under the buyer's control. Check the first unit before the box goes into stock, rather than at the point of use.
- Look for the CE mark on the sterile pouch.
- Confirm the gauge and length on the label match what was ordered.
- Read the product code and confirm it is the thread type intended.
- Check the manufacturing date and the expiry date, and work out how much shelf life remains.
- Match the batch number on the pouch against the outer bag and the invoice.
- Examine the seal: it should be fully intact, with no lifting, no resealing marks and no adhesive residue.
If any step does not match, stop before opening the pouches and email sherry@fillertop.com with photographs of the outer bag, the pouch and the label. An intact pouch can be investigated and replaced. A pouch that has already been opened cannot be assessed by anyone, which makes the process harder for both parties, so photograph first.
11. Documents we will send you
These are available to any buyer, on request, with no minimum order:
- CE certificate and declaration of conformity: the documents behind the CE mark, with the scope relevant to the product line you are ordering
- Product specification sheet — thread type, gauge, needle length, thread length and suture thickness
- Batch information — for the batch supplied on your order, to the extent we are able to provide it
- Technical and packaging information: sterilisation method, packaging configuration, storage and handling
Request them at sherry@fillertop.com with the product or product line you need them for. Where a document you need does not exist, we will tell you it does not exist rather than send you something adjacent.
12. Regulatory status by market
CE marking applies to the European market. Other markets require their own clearance or registration, and the requirements differ from country to country, sometimes substantially, including for products that look identical on the outside.
If you need to confirm the regulatory position for your market before ordering, ask us. We will tell you what we know about our own documentation, and we will be equally clear about what we do not know. This is a short conversation before a shipment is booked and a considerably longer one after a consignment is held at the border.
13. For practitioners and trade buyers
We supply two kinds of buyer from this site, and they need different things from a page like this one.
Practitioners and clinics. If you are ordering for your own treatment room, the sections that matter most are the delivery inspection checklist above and the shelf-life check in section 6, since both protect treatments scheduled for the coming weeks. Our threads are supplied for use by trained professionals.
Clinics, distributors and agents buying in volume. You will typically need the documents listed in section 11 for your own regulatory or import process, and consistency of specification across repeat orders. Tell us the thread types, gauges and quantities you need and we will quote you. Custom packaging with your own branding is available on request, and we work with agents and distributors. Get in touch to discuss terms.
To start either conversation, email sherry@fillertop.com, or use our enquiry form. Including the thread types and gauge sizes you are interested in will save a round trip.
14. Contact us
- Company: NEWBEAUTY TECHNOLOGY LIMITED
- Email: sherry@fillertop.com
- Phone: +86 15383044462
- Address: Room 701, Unit 108, 7/F, Tower B, New Mandarin Plaza, 14 Science Museum Road, Tsim Sha Tsui, Kowloon, Hong Kong
- Response time: within 24 hours on business days
If your question concerns an order you already have, put the order number and, where relevant, the batch number in the subject line so that we can look it up straight away.