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Heel stick safety lancet
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref NoModel HHZ-II, HHZ-III, HHZ-IV
Identity
- Device Name
- Heel stick safety lancet EUDAMED
- Model / Reference
- HHZ-II, HHZ-III, HHZ-IV EUDAMEDNo EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06957138607851 EUDAMED
- Basic UDI-DI
- 69571386HSSL05YT EUDAMED
- Unit of Use DI
- 56957138607856 EUDAMED
- EMDN Code
- V010401 LANCETS WITH SAFETY SYSTEMS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Northern Ireland EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Heel stick safety lancet by Tianjin Huahong Technology Co., Ltd. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K220372 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K252490 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 69571386HSSL05YT | Class IIa | Active |
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Manufacturer
- Manufacturer
- Tianjin Huahong Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000015849
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED dea805cd-d094-4a73-b486-158cf7151ab9 61 fields · synced Jun 18, 2026
- FDA 510(k) K220372 1 fields · synced May 18, 2026