Identity
- Device Name
- MASTDISCS®AST Cefotaxime 5µg Cartridge discs EUDAMED
- Model / Reference
- CTX5C EUDAMED
Identifiers
- Primary DI / UDI-DI
- 15060392370718 EUDAMED
- Basic UDI-DI
- 50561527CTX5LT EUDAMED
- Direct Marketing DI
- 15060392370718 EUDAMED
- EMDN Code
- W0104080502 IMPREGNATED DISKS, MULTI-DISKS & TABLETS 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®AST Cefotaxime 5µg Cartridge 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 | 50561527CTX5LT | 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 5f22ca95-bd4d-498a-b7f7-29078d6dbfb4 61 fields · synced Jul 14, 2026