Identity
- Trade Name
- UREA BROTH BASE EUDAMEDFDA UDI
- Generic Name
- Differential/selective broth culture medium IVD FDA UDI
- Device Name
- UREA BROTH BASE EUDAMED
- Model / Reference
- CM0071B EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 05032384001422 EUDAMEDFDA UDI
- Basic UDI-DI
- 5032384UreaBrothOLNN EUDAMED
- FDA Product Code
- JSH FDA UDI
- EMDN Code
- W0104010101 DEHYDRATED CULTURE MEDIA (DCM) EUDAMED
- GMDN Term
- Differential/selective broth culture medium IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 866.2320 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Urea Broth Base by Oxoid Ltd — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 5032384UreaBrothOLNN | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Oxoid Ltd
- EUDAMED SRN
- GB-MF-000016914
- Authorised Representative
- Thermo Fisher Diagnostics B.V. NL-AR-000013157
Sources (2)
- EUDAMED 914cadad-c68c-47bf-8dd9-d1e2548f8ae6 61 fields · synced Jul 31, 2026
- FDA UDI 43dbaa7f-de68-4036-b2b4-3f057a2e1228 32 fields · synced May 30, 2026