Since Brexit, Great Britain runs its own medical-device route. A CE mark and a EUDAMED entry no longer get a product onto the GB market, and a UK buyer who only sees CE paperwork is looking at the wrong document.
Here is what Quanzhou Honglinkai New Material Co., Ltd. (“HLK”) holds for the United Kingdom, and how any UK importer can check it without taking our word for it.
1. MHRA manufacturer registration — status: registered
The Medicines and Healthcare products Regulatory Agency (MHRA) is the UK Competent Authority. Manufacturers of medical devices placed on the GB market must register with MHRA, and the registration is made through the UK Responsible Person.
| Field | Record |
|---|---|
| Authority | MHRA (Medicines and Healthcare products Regulatory Agency) |
| Application submitted | 13 April 2026 |
| Confirmation issued | 20 April 2026 |
| Manufacturer registration status | Registered |
| MHRA reference number | 38014 |
| Manufacturer | Quanzhou Honglinkai New Material Co., Ltd. |
| Address | No.299 Xingxian Road, Licheng District, Quanzhou City, Fujian Province, 362000, China |
| UK Responsible Person | Intercert Global Ltd, 85 Great Portland Street, First Floor, London, W1W 7LT |
| Device registered | GMDN 66302 — External nasal dressing |
| Device registered | GMDN 67430 — Nasal breathing mouth tape |
| Public record | Open the MHRA PARD entry for HLK ↗ — reference 38014 |
2. UKCA Declaration of Conformity, per SKU
Each product line carries its own UK Declaration of Conformity, issued under the sole responsibility of the manufacturer:
| SKU | Product | Model | Classification | Date |
|---|---|---|---|---|
| UKCA DoC | Nasal Strips | HLKNS1 | Class I | 12 March 2026 |
| UKCA DoC | Mouth Tape | HLKMT1 | Class I | 12 March 2026 |
Both declare conformity via the UK Declaration of Conformity route — Part II of the UK MDR 2002, Annex I as modified by Part II of Schedule 2A to the UK MDR 2002, and Annex X as modified accordingly. As Class I devices they are self-declared: there is no notified body, and the DoC records “Notified Body: N/A”. A Technical Construction File is held for each SKU and retained at the manufacturer’s premises.
Standards applied to both SKUs:
- EN ISO 14971:2019 — risk management
- EN ISO 10993-1:2020, -5:2009, -10:2023, -23:2021 — biological evaluation (cytotoxicity, irritation, sensitisation)
- EN ISO 15223-1:2021 — symbols for labelling
- EN ISO 20417:2021 — information supplied by the manufacturer
3. How to verify it — the UK is genuinely public
Unlike some jurisdictions, the UK publishes its register. The MHRA Public Access Registration Database (PARD) at pard.mhra.gov.uk lets anyone look up:
- registered manufacturers and their addresses
- the MHRA reference (account) number
- the medical device types registered, by GMDN term
- the brand or trade names of registered devices
- the UK Responsible Person name and address for each manufacturer record
You can search by manufacturer name, address or MHRA reference number. HLK’s record shows the GMDN device types above together with Intercert Global Ltd as UK Responsible Person — the same entity named on our declarations of conformity. Nothing here depends on a document we send you.
Skip the search — open our entry directly: Quanzhou Honglinkai New Material Co., Ltd. — MHRA reference 38014 ↗ No account and no login. That is the register page itself, not a copy we made.
Two halves of the same record. This page is HLK’s own public record of the UK route — what we hold, at which SKU scope, and under which limits. The Trust & Compliance page gathers all of our public registrations in one place. The PARD entry is the official half: it is the register we are checked against, and the one we cannot edit. Use both:
| What you want to confirm | Where to check |
|---|---|
| What HLK states it holds for the UK — and what it does not claim | This page, and Trust & Compliance |
| That the MHRA registration exists, and who the UK Responsible Person is | Our MHRA PARD entry ↗ — official, public, reference 38014 |
| Which standards a given SKU is declared against | The per-SKU UKCA DoC (shown above; full copy on request) |
If a statement on this page and the PARD entry ever disagree, treat the register as authoritative and tell us — we will correct the page. That is the point of publishing the route instead of just asserting it.
4. What this is not
The MHRA is explicit about this, and so are we:
- Registration is not approval, certification or endorsement. MHRA states that registration of medical devices with the MHRA does not represent any form of accreditation, certification, approval or endorsement by the MHRA — and that it is not permitted to claim otherwise, or to use MHRA logos in marketing materials. We make no such claim and use no MHRA logo.
- Class I is self-declared. There is no notified-body certificate to show, because the route does not require one. Anyone offering you a “UKCA certificate” for a Class I device should be asked what body issued it.
- The UKCA DoC is per SKU, not per company. A DoC for nasal strips does not cover mouth tape. Ask for the declaration that names your exact product and model.
- UKCA is GB, not EU. Great Britain uses UKCA; the EU uses CE. Northern Ireland has its own arrangements. A UK registration does not replace the EU route, and vice versa.
5. The three market routes, side by side
| Market | Route | What HLK holds | Public lookup |
|---|---|---|---|
| UK (GB) | UKCA / UK MDR 2002 | MHRA manufacturer registration + per-SKU UKCA DoC | MHRA PARD — our record ↗ |
| EU | CE / EU MDR 2017/745 | EUDAMED manufacturer SRN + per-SKU DoC | EUDAMED ↗ |
| US | Cosmetic / MoCRA 2022 | FDA cosmetic facility registration + product listing | Not public — FEI Search Portal only (explained here) |
If you sell into more than one of these, the paperwork is not interchangeable. The EU records are broken down here, and the US route is explained here.
Want the UK pack?
For a serious OEM enquiry we send the documentation directly — MHRA registration confirmation, UKCA declarations of conformity for your SKU, technical construction file summary, ISO 10993 test reports, REACH SVHC letter, PFAS-free test and batch-level CoC. Same business day; no NDA required for general documentation.
Request the UK compliance pack →
HLK — Quanzhou Honglinkai New Material Co., Ltd. — MHRA registered manufacturer (UK Responsible Person: Intercert Global Ltd) | UKCA DoC for nasal strips (HLKNS1) and mouth tape (HLKMT1) | EUDAMED SRN CN-MF-000049679 | OEM/ODM for nasal strips, mouth tape and body patches since 2005.
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