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Alphacheck Klinik
EUDAMEDClass IIa (EU MDR)
Ref SL-28-16MModel Type A, Type B, Type C, Type T, Type MRef SL-23-18M
Identity
- Trade Name
- Alphacheck Klinik EUDAMED
- Device Name
- Safety Blood Lancets EUDAMED
- Model / Reference
- Type A, Type B, Type C, Type T, Type M EUDAMEDSL-28-16M EUDAMEDSL-23-18M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971227402400 EUDAMED06971227402394 EUDAMED
- Basic UDI-DI
- 697122740SLYU EUDAMED
- Unit of Use DI
- 86971227402406 EUDAMED86971227402390 EUDAMED
- EMDN Code
- V010401 LANCETS WITH SAFETY SYSTEMS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Sweden 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
Alphacheck Klinik by Promisemed Hangzhou Meditech Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 697122740SLYU | 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 89607b88-3d30-45b0-9fcd-e7d0ddb8242d 61 fields · synced Oct 6, 2026
- EUDAMED 5b410f00-5d4b-4d9d-8bed-4303dcd5c953 61 fields · synced May 17, 2026