Identity
- Device Name
- MASTDISCS® ID Oxidase Discs EUDAMED
- Model / Reference
- D57C EUDAMED
Identifiers
- Primary DI / UDI-DI
- 15060392370275 EUDAMED
- Basic UDI-DI
- 50561527D57PV EUDAMED
- Direct Marketing DI
- 15060392370275 EUDAMED
- EMDN Code
- W0104080208 SINGLE TESTS (DISCS, STRIPS, DROPPERS...) EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
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
MASTDISCS® ID Oxidase Discs by Mast Group Limited — 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 | 50561527D57PV | Class B | Active |
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Manufacturer
- Manufacturer
- Mast Group Limited
- EUDAMED SRN
- GB-MF-000025209
- Authorised Representative
- Mast Diagnostica GmbH DE-AR-000005299
Sources (1)
- EUDAMED b1aa185a-3a41-4af7-bc63-69cce77a6045 61 fields · synced Jul 15, 2026