Identity
- Trade Name
- FOX30 CEFOXITIN EUDAMEDNA FDA UDI
- Generic Name
- Cefoxitin susceptibility testing disc IVD FDA UDI
- Device Name
- CEFOXITIN EUDAMED
- Model / Reference
- CT0119B EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 05032384006304 EUDAMEDFDA UDI
- Basic UDI-DI
- 5032384Cefoxitin8S EUDAMED
- 510(k) Number
- K860153 FDA UDI
- FDA Product Code
- JTN FDA UDI
- EMDN Code
- W0104080502 IMPREGNATED DISKS, MULTI-DISKS & TABLETS EUDAMED
- GMDN Term
- Cefoxitin susceptibility testing disc IVD FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass II FDA UDI
- Regulation Number
- 866.1620 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
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
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Fox30 Cefoxitin by Oxoid Ltd — Class B — 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 | 5032384Cefoxitin8S | Class B | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class B | 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 (3)
- EUDAMED 1386bf98-9480-48cb-9aa9-2e3714f8fcc9 61 fields · synced Jun 19, 2026
- FDA UDI 122d6ac7-7166-4d5e-9a6e-83a10fd57339 34 fields · synced May 30, 2026
- EUDAMED 9b947a59-7d81-4a22-96cb-11b1b4cd7370 61 fields · synced Jun 14, 2026