Identity
- Device Name
- Heel Blood Lancet EUDAMED
- Model / Reference
- HB-100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975965291623 EUDAMED
- Basic UDI-DI
- 697122740HBX7 EUDAMED
- Unit of Use DI
- 86975965291629 EUDAMED
- EMDN Code
- V010401 LANCETS WITH SAFETY SYSTEMS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Greece 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
Heel Blood Lancet by Promisemed Hangzhou Meditech Co., Ltd. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
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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 | K221371 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K193009 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 697122740HBX7 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Promisemed Hangzhou Meditech Co., Ltd.
- EUDAMED SRN
- CN-MF-000008465
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED 399ca8bc-e306-47b2-8747-d308171b72c3 61 fields · synced Oct 8, 2026
- FDA 510(k) K221371 1 fields · synced May 18, 2026