Identity
- Trade Name
- Mission trinity EUDAMEDMission Trinity R, Level 3 FDA UDI
- Generic Name
- Multiple blood gas analyte IVD, control FDA UDI
- Device Name
- Mission Trinity R Level 3 EUDAMEDFor monitoring the performance of blood gas, electrolyte, metabolite, and CO-Oximeter (Radiometer) instrumentation for the analytes and analyzers listed on the Expected Values Chart. FDA UDI
- Model / Reference
- DD-97003 EUDAMEDFDA UDI
- Description
- For monitoring the performance of blood gas, electrolyte, metabolite, and CO-Oximeter (Radiometer) instrumentation for the analytes and analyzers listed on the Expected Values Chart. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00811403014866 EUDAMEDFDA UDI
- Basic UDI-DI
- 081140301DD97003AB EUDAMED
- FDA Product Code
- JJY FDA UDI
- EMDN Code
- W0101050399 CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER EUDAMED
- GMDN Term
- Multiple blood gas analyte IVD, control FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 862.1660 FDA UDI
- Market of Registration
- Hungary 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Mission trinity by DIAMOND DIAGNOSTICS Inc — 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 | 081140301DD97003AB | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Diamond Diagnostics Inc
- EUDAMED SRN
- US-MF-000035435
- Authorised Representative
- Diamond Diagnostics Inc. Magyarországi Fióktelepe HU-AR-000034351
Sources (2)
- EUDAMED 2bf4ffaa-b952-4a91-afe3-9752e48a9602 61 fields · synced Jun 20, 2026
- FDA UDI 3ff3e1c2-0dbd-4b51-a37e-976048e629ac 33 fields · synced May 30, 2026