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Modified Karmali Selective Supplement
EUDAMEDFDA UDIClass A (EU MDR)
Ref SR0205E
by Oxoid Ltd
Identity
- Trade Name
- MODIFIED KARMALI SELECTIVE SUPPLEMENT EUDAMEDMODIFIED KARMALI SEL. SUPP. FDA UDI
- Generic Name
- Culture medium antimicrobial supplement IVD FDA UDI
- Device Name
- MODIFIED KARMALI SELECTIVE SUPPLEMENT EUDAMED
- Model / Reference
- SR0205E EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 05032384085811 EUDAMEDFDA UDI
- Basic UDI-DI
- 5032384KarmaliSelSup3S EUDAMED
- FDA Product Code
- JSK FDA UDI
- EMDN Code
- W0104010104 ADDITIVES FOR DCM (GROWTH SUPPLEMENTS, SELECTIVE AGENTS, ...) EUDAMED
- GMDN Term
- Culture medium antimicrobial supplement IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 866.2450 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
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
Modified Karmali Selective Supplement 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 | 5032384KarmaliSelSup3S | 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 e9bf7c07-a761-408a-b714-bd6499a39810 61 fields · synced Jul 19, 2026
- FDA UDI 52f1a6b5-413c-45b6-92ee-89279cf7cc87 32 fields · synced May 30, 2026