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Hamex
EUDAMEDClass IIa (EU MDR)
Ref SL-21-22M2Model Type A, Type B, Type C, Type T, Type M
Identity
- Trade Name
- HAMEX EUDAMED
- Device Name
- Safety Blood Lancets EUDAMED
- Model / Reference
- Type A, Type B, Type C, Type T, Type M EUDAMEDSL-21-22M2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975965296901 EUDAMED
- Basic UDI-DI
- 697122740SLYU EUDAMED
- Unit of Use DI
- 86975965296907 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
Hamex 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 | 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 (1)
- EUDAMED f48028ec-1456-42ed-a867-013efcb55877 61 fields · synced Jun 19, 2026