Identity
- Trade Name
- Medicare EUDAMED
- Device Name
- Blood Lancets EUDAMED
- Model / Reference
- BL-28G EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975965292194 EUDAMED06975965292200 EUDAMED
- Basic UDI-DI
- 697122740BLX9 EUDAMED
- Unit of Use DI
- 86975965292190 EUDAMED86975965292206 EUDAMED
- EMDN Code
- V010402 LANCETS WITHOUT SAFETY SYSTEMS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
Medicare by Promisemed Hangzhou Meditech Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697122740BLX9 | 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 ae7be6dc-3135-4c6e-9bd2-45c2f3bddd9b 61 fields · synced Oct 7, 2026
- EUDAMED 006f6b0b-da4d-4329-8e33-b09721bc732c 61 fields · synced May 19, 2026