Identity
- Trade Name
- SALINE TABLETS EUDAMEDFDA UDI
- Generic Name
- Saline suspension medium/diluent IVD FDA UDI
- Device Name
- SALINE TABLETS EUDAMED
- Model / Reference
- BR0053G EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 05032384028207 EUDAMEDFDA UDI
- Basic UDI-DI
- 5032384SalineTablets62 EUDAMED
- FDA Product Code
- JSC FDA UDI
- EMDN Code
- W010499 MICROBIOLOGY TESTS - OTHER EUDAMED
- GMDN Term
- Saline suspension medium/diluent 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
No
EUDAMED
Microbial Substances
No
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
Saline Tablets 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 | 5032384SalineTablets62 | 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 95b7a0e9-cafe-48b9-86d6-50748dabe250 61 fields · synced Jul 21, 2026
- FDA UDI 150c9054-56b7-41ea-9ddd-cae61b11b187 32 fields · synced May 30, 2026