US buyers ask a different question from EU buyers. An EU importer wants a CE route and a EUDAMED SRN. A US buyer wants one thing confirmed before placing a private-label order: is this facility registered with the FDA, so my product listing goes through and my shipment clears?
Here is exactly what Quanzhou Honglinkai New Material Co., Ltd. (“HLK”) holds for the United States — and, just as importantly, what we do not claim.
What HLK holds: cosmetic facility registration under MoCRA
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) requires cosmetic facilities that manufacture or process products for the US market to register with the FDA and to list each product. HLK filed through FDA Cosmetics Direct, the agency’s own electronic submission portal, and the submission was accepted on 13 May 2026.
| Field | Record |
|---|---|
| Registration type | Cosmetic facility registration + cosmetic product listing |
| Legal framework | MoCRA (FD&C Act, as amended 2022) |
| Submitted via | FDA Cosmetics Direct (official FDA portal) |
| Status | Submission accepted |
| Effective date | 13 May 2026 |
| Facility | Quanzhou Honglinkai New Material Co Ltd |
| Facility FEI | 3041672188 |
| Address | No.299 Xingxian Road, Quanzhou City, Fujian Province, 362000, China |
| Brand | HLK |
| US Agent | UNICO AMERICA CO., LTD. |
| Product category code | (17) Other preparations |
| Renewal | Biennial — next due May 2028 |
The five cosmetic product listings
The registration covers HLK’s five US-facing cosmetic product lines:
| # | Listed cosmetic product |
|---|---|
| 1 | Magnetic nose strips |
| 2 | Nasal Strips |
| 3 | Mouth Tape |
| 4 | Face Tape |
| 5 | Sports Tape |
That list matters for a brand owner. If your SKU is one of these categories, your own product listing can reference an already-registered facility instead of starting the paperwork from zero.
How to verify it — and why most “FDA certificates” cannot be verified
Most supplier claims of “FDA registration” cannot be checked the way a EUDAMED SRN can. Under MoCRA, FDA does not publish a public, name-searchable database of cosmetic facility registrations or product listings — that information is confidential and visible only to the registered account holder in Cosmetics Direct. So there are two honest routes:
| What you can check | Where | What it confirms |
|---|---|---|
| FEI number | FDA FEI Search Portal (fda.gov) | That the facility has an FEI on file. Note that not every FEI is releasable through the portal |
| Registration & listing detail | FDA Cosmetics Direct — account holder only | The facility registration and the product listings |
| A copy of the submission | Ask HLK | We send the Cosmetics Direct confirmation with the compliance pack |
A word of caution that applies to every supplier, not just HLK: FDA states plainly that it does not issue certificates of registration, and does not recognise any certificate of registration. A gold-bordered “FDA certificate” bearing the FDA logo and an eagle is almost always issued by a commercial US-agent service, not by the agency — and the certificate itself usually says so in small print. The genuine artefact is a screenshot or export from Cosmetics Direct. Ours is shown above.
What this registration is not
This is the part most supplier pages leave out.
- Not FDA approval, certification or clearance. FDA does not approve or certify cosmetics. Facility registration and product listing are legal obligations, not endorsements — the agency says so itself.
- No 510(k). A 510(k) is a premarket submission for a medical device. HLK does not hold one and does not claim one. Our US route for nasal strips, mouth tape, face tape and sports tape is the cosmetic pathway — which is exactly why these products appear as cosmetic listings.
- Not a licence to make medical claims. Registration does not turn a cosmetic into a treatment for snoring or sleep apnoea. US-facing copy must stay on the cosmetic and wellness side of that line, and HLK makes no clinical efficacy claims for these products.
- Not transferable. The registration belongs to HLK. The brand owner, as responsible person, files its own product listing and references our FEI.
Why it matters to a US buyer
- Your listing depends on it. A product listing submission requires the facility registration number of the facility that manufactures the product. No FEI, no listing.
- Import risk. Products from an unregistered facility can be detained or refused at the US border.
- No fee excuse. Cosmetic facility registration carries no federal registration fee — unlike medical devices, which pay an annual establishment fee. There is no cost reason for a supplier to stay unregistered.
Can HLK handle the US filing for you?
Yes — and this is where most suppliers stop, because the answer depends on who is named on the label.
Under MoCRA the two filings are separate, and they belong to different parties:
- Facility registration — filed by the facility that manufactures the product. Ours is done (FEI 3041672188).
- Product listing — filed by the responsible person, which MoCRA defines as the manufacturer, packer or distributor whose name appears on the product label. There is exactly one per product, and it is a label question, not a contractual one.
That gives two workable routes for an OEM customer:
| Your situation | Responsible person | What HLK does |
|---|---|---|
| Your brand name is on the label | You | We supply the facility FEI, the INCI ingredient list and the product documentation, and support your Cosmetics Direct submission |
| HLK is named on the label as manufacturer | HLK | We file the cosmetic product listing for the product |
Either way we also:
- Coordinate the US Agent requirement through our appointed agent, UNICO AMERICA CO., LTD.
- Keep you on the maintenance cycle — listings are updated annually, facility registration is renewed biennially (ours next falls due May 2028).
- Flag when a formulation, supplier or label change triggers a listing update, which is due within 60 days.
What we cannot do — and no supplier can — is obtain “FDA approval”. FDA states plainly that cosmetic facility registration and product listing is neither a cosmetic approval program nor a promotional tool, and that it issues no certificates for either. A supplier offering an FDA approval document for a cosmetic is offering something that does not exist.
Ask which route applies to your label →
Pair it with the EU and UK records
HLK’s US cosmetic registration sits alongside three verifiable EU and China public records — the EUDAMED manufacturer SRN, the ISO 9001:2015 certificate on CNCA, and the China Customs credit record. The full breakdown, with lookup links, is in HLK on EU EUDAMED: 3 verifiable public records. For Great Britain, the UKCA and MHRA route is covered in UKCA & MHRA: what HLK holds for the UK market.
Want the compliance pack?
For a serious OEM enquiry we send the documentation directly — US cosmetic facility registration confirmation, EU DoC, ISO 13485 chain statement, REACH SVHC letter, RoHS 2.0, PFAS-free test, MSDS and batch-level CoC. Same business day; no NDA required for general documentation.
HLK — Quanzhou Honglinkai New Material Co., Ltd. — FDA cosmetic facility registration (MoCRA, FEI 3041672188) | EUDAMED SRN CN-MF-000049679 | ISO 9001:2015 | OEM/ODM for nasal strips, mouth tape and body patches since 2005.
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