Identity
- Trade Name
- CFP75 CEFOPERAZONE EUDAMEDNA FDA UDI
- Generic Name
- Cefoperazone susceptibility testing disc IVD FDA UDI
- Device Name
- CEFOPERAZONE EUDAMED
- Model / Reference
- CT0249B EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 05032384006564 EUDAMEDFDA UDI
- Basic UDI-DI
- 5032384CefoperazoneBB EUDAMED
- 510(k) Number
- K860153 FDA UDI
- FDA Product Code
- JTN FDA UDI
- EMDN Code
- W0104080502 IMPREGNATED DISKS, MULTI-DISKS & TABLETS EUDAMED
- GMDN Term
- Cefoperazone 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
Cfp75 Cefoperazone 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 | 5032384CefoperazoneBB | 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 41609344-05f1-4e06-a704-3da02629f807 61 fields · synced Jul 9, 2026
- FDA UDI 1caddd4e-f1df-4831-b9af-4f2f6ed427dd 34 fields · synced May 29, 2026
- EUDAMED 9d845658-881b-4ed7-a6a9-2022bbeb61a1 61 fields · synced Jul 9, 2026