Identity
- Trade Name
- Eurotrol FDA UDI
- Generic Name
- Multiple blood gas/haemoximetry/electrolyte analyte IVD, control FDA UDI
- Model / Reference
- 179.003.010 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08718734960911 FDA UDI
- 510(k) Number
- K121468 FDA UDI
- FDA Product Code
- JJY FDA UDI
- GMDN Term
- Multiple blood gas/haemoximetry/electrolyte analyte IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1660 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Eurotrol by Eurotrol B.V. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Eurotrol B.V.
Sources (1)
- FDA UDI c26360f8-9546-4760-9ea1-455c427a3127 34 fields · synced Jun 6, 2026