← Back to catalogue
Tryptone Soya Broth Ep/Usp/Bp/Jp
EUDAMEDFDA UDIClass A (EU MDR)
Ref CM0129T
by Oxoid Ltd
Identity
- Trade Name
- TRYPTONE SOYA BROTH EP/USP/BP/JP EUDAMEDTRYPTONE SOYA BROTH FDA UDI
- Generic Name
- Enriched broth culture medium IVD FDA UDI
- Device Name
- TRYPTONE SOYA BROTH EUDAMED
- Model / Reference
- CM0129T EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 05032384001767 EUDAMEDFDA UDI
- Basic UDI-DI
- 5032384TryptSoyaBrothOL8J EUDAMED
- FDA Product Code
- JSC FDA UDI
- EMDN Code
- W0104010101 DEHYDRATED CULTURE MEDIA (DCM) EUDAMED
- GMDN Term
- Enriched broth culture medium IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 866.2350 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Tryptone Soya Broth Ep/Usp/Bp/Jp 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 | 5032384TryptSoyaBrothOL8J | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Oxoid Ltd
- EUDAMED SRN
- GB-MF-000016914
- Authorised Representative
- Thermo Fisher Diagnostics B.V. NL-AR-000013157
Sources (2)
- EUDAMED e11f6560-1b0d-4e87-a77b-76445a6432e4 61 fields · synced Jul 13, 2026
- FDA UDI 0367a2dc-fefd-4ed4-baa4-1d65735e7fb6 32 fields · synced May 30, 2026