Identity
- Trade Name
- CAMPYGEN (3.5 LITRES) EUDAMEDFDA UDI
- Generic Name
- Atmospheric generation kit IVD FDA UDI
- Device Name
- CAMPYGEN EUDAMED
- Model / Reference
- CN0035A EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 05032384028887 EUDAMEDFDA UDI
- Basic UDI-DI
- 5032384CampygenCL EUDAMED
- FDA Product Code
- KZJ FDA UDI
- EMDN Code
- W0104010999 ENVIRONMENTAL GENERATING SYSTEMS - OTHER EUDAMED
- GMDN Term
- Atmospheric generation kit IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 866.2580 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
No
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
Campygen (3.5 Litres) 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 | 5032384CampygenCL | 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 e5fd8dbf-3d9a-453b-a511-e0b21ad10c06 61 fields · synced Jun 19, 2026
- FDA UDI 70fc504b-4f8e-4593-96c6-d2138bfa6ebd 32 fields · synced May 30, 2026