Identity
- Trade Name
- DERMASEL AGAR BASE EUDAMEDFDA UDI
- Generic Name
- Differential/selective agar culture medium IVD FDA UDI
- Device Name
- DERMASEL AGAR EUDAMED
- Model / Reference
- CM0539B EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 05032384003457 EUDAMEDFDA UDI
- Basic UDI-DI
- 5032384DermaselAgrOLUS EUDAMED
- FDA Product Code
- JSG FDA UDI
- EMDN Code
- W0104030101 DCM FOR YEASTS AND FUNGI EUDAMED
- GMDN Term
- Differential/selective agar culture medium IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 866.2300 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
Dermasel Agar 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 | 5032384DermaselAgrOLUS | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Oxoid Ltd
- EUDAMED SRN
- GB-MF-000016914
- Authorised Representative
- Thermo Fisher Diagnostics B.V. NL-AR-000013157
Sources (2)
- EUDAMED fa753bd1-2911-42d4-a7d8-7e2b8a7fb5b6 61 fields · synced Jun 19, 2026
- FDA UDI 12211ae5-5f8f-4046-9570-b866be4560bf 32 fields · synced May 30, 2026