Identity
- Trade Name
- α1-Microglobulin EUDAMED
- Device Name
- a1-Microglobulin EUDAMED
- Model / Reference
- 08944547190 EUDAMED08944539190 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04987503610126 EUDAMED04987503610119 EUDAMED
- Basic UDI-DI
- 4987503A1MGUWK EUDAMED
- EMDN Code
- W0102019004 A1-MICROGLOBULIN EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
α1-Microglobulin by Denka Co., Ltd. — Class B — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 4987503A1MGUWK | Class B | Active |
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Manufacturer
- Manufacturer
- Denka Co., Ltd.
- EUDAMED SRN
- JP-MF-000015952
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (2)
- EUDAMED c8addf3f-87a8-4ecf-8327-ff236f970af3 61 fields · synced Aug 2, 2026
- EUDAMED cb92086c-45c1-4e5f-b418-f300ccd802e2 61 fields · synced May 17, 2026