Identity
- Trade Name
- MUELLER HINTON AGAR EUDAMEDNA FDA UDI
- Generic Name
- Mueller-Hinton agar antimicrobial susceptibility culture medium IVD FDA UDI
- Device Name
- MUELLER-HINTON AGAR EUDAMED
- Model / Reference
- CM0337B EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 05032384002610 EUDAMEDFDA UDI
- Basic UDI-DI
- 5032384MuellerHintonOL97 EUDAMED
- 510(k) Number
- K802498 FDA UDI
- FDA Product Code
- JTZ FDA UDI
- EMDN Code
- W0104010101 DEHYDRATED CULTURE MEDIA (DCM) EUDAMED
- GMDN Term
- Mueller-Hinton agar antimicrobial susceptibility 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
Mueller Hinton 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 | 5032384MuellerHintonOL97 | 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 20b4ef4a-e553-4996-8be7-a241c9266a4f 61 fields · synced Jul 14, 2026
- FDA UDI 6f51c8b2-a387-4176-9022-e14ae2ee1e39 34 fields · synced May 30, 2026