Identity
- Trade Name
- α1-Microglobulin Calibrator Set EUDAMED
- Device Name
- α1-Microglobulin Calibrator Set EUDAMED
- Model / Reference
- 08944474190 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04987503610102 EUDAMED
- Basic UDI-DI
- 4987503A1MGUcal6J EUDAMED
- EMDN Code
- W0102152203 SPECIFIC PROTEIN STANDARDS AND CALIBRATORS EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
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 Calibrator Set 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 | 4987503A1MGUcal6J | 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 (1)
- EUDAMED c079502d-236b-4e04-b068-c5af0e0d8555 61 fields · synced Jul 14, 2026