Identity
- Trade Name
- HEKTOEN ENTERIC AGAR EUDAMED
- Device Name
- HEKTOEN ENTERIC AGAR EUDAMED
- Model / Reference
- CM0419AU EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05032384575015 EUDAMED
- Basic UDI-DI
- 5032384HektoenEntAgrOLFL EUDAMED
- EMDN Code
- W0104010101 DEHYDRATED CULTURE MEDIA (DCM) EUDAMED
Classification
- Device Class
- Class A EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
Yes
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
Hektoen Enteric Agar by Oxoid Ltd — Class A — 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 | 5032384HektoenEntAgrOLFL | Class A | Active |
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Manufacturer
- Manufacturer
- Oxoid Ltd
- EUDAMED SRN
- GB-MF-000016914
- Authorised Representative
- Thermo Fisher Diagnostics B.V. NL-AR-000013157
Sources (1)
- EUDAMED b42341c1-2ebd-4467-9b32-344d5beb720a 61 fields · synced Jun 19, 2026