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Wilkins Chalgren Anaerobe Agar
EUDAMEDFDA UDIClass A (EU MDR)
Ref CM0619BRef CM0619W
by Oxoid Ltd
Identity
- Trade Name
- WILKINS CHALGREN ANAEROBE AGAR EUDAMEDNA FDA UDI
- Generic Name
- Antimicrobial activity testing agar culture medium IVD FDA UDI
- Device Name
- WILKINS CHALGREN ANAEROBE AGAR EUDAMED
- Model / Reference
- CM0619B EUDAMEDFDA UDICM0619W EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05032384003679 EUDAMEDFDA UDI05032384510757 EUDAMED
- Basic UDI-DI
- 5032384WilkinsChalgAgr5U EUDAMED
- FDA Product Code
- JSO FDA UDI
- EMDN Code
- W0104010101 DEHYDRATED CULTURE MEDIA (DCM) EUDAMED
- GMDN Term
- Antimicrobial activity testing agar culture medium IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass II FDA UDI
- Regulation Number
- 866.1700 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Wilkins Chalgren Anaerobe Agar 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 | 5032384WilkinsChalgAgr5U | 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 (3)
- EUDAMED a5ca83cf-606e-48e8-8a0f-d336fb34fdd4 61 fields · synced Jun 20, 2026
- EUDAMED c35d5da6-1bae-4c2f-b176-7dff4820c192 61 fields · synced May 18, 2026
- FDA UDI 39de2205-41d9-438e-8266-5a450a15119d 33 fields · synced May 29, 2026