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Safety lancet
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref NoModel XXVI, XXIX, XXXIII, XXXV 510(k) K260191
Identity
- Device Name
- Safety lancet EUDAMED
- Model / Reference
- XXVI, XXIX, XXXIII, XXXV EUDAMEDNo EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06957138610639 EUDAMED
- Basic UDI-DI
- 69571386SL06X4 EUDAMED
- Unit of Use DI
- 56957138610634 EUDAMED
- EMDN Code
- V010401 LANCETS WITH SAFETY SYSTEMS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy 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
Category: Blood lancet, single-use
Safety lancet by Tianjin Huahong Technology Co., Ltd. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
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Also classified as Blood lancet, single-use.
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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 | K260191 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K241627 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 69571386SL06X4 | 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 e7cfe2f3-eae9-4703-a209-36993a6e213c 85 fields · synced Jun 18, 2026
- FDA 510(k) K260191 1 fields · synced May 18, 2026