Identity
- Trade Name
- Mission trinity kit EUDAMEDMission trinity EUDAMEDMission Trinity R, Level 2 FDA UDIMission Trinity B Level 1-2-3 FDA UDI
- Generic Name
- Multiple blood gas analyte IVD, control FDA UDI
- Device Name
- Mission Trinity B Level 1-2-3 EUDAMEDMission Trinity R Level 2 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 UDIFor monitoring the performance of blood gas, electrolyte, metabolite, and CO-Oximeter. FDA UDI
- Model / Reference
- DD-96123 EUDAMEDFDA UDIDD-97002 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 UDIFor monitoring the performance of blood gas, electrolyte, metabolite, and CO-Oximeter. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00811403014835 EUDAMEDFDA UDI00811403014859 EUDAMEDFDA UDI
- Basic UDI-DI
- 081140301DD96123AF EUDAMED081140301DD97002A9 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 UDIFDA 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 UDIFDA 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 kit 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 | 081140301DD96123AF | 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 (4)
- EUDAMED e636da0b-9c0c-4d46-9d5b-83b322665c97 61 fields · synced Jul 23, 2026
- FDA UDI a0cd4e5a-90d8-4d0b-8f9b-f2fbdc8ce538 33 fields · synced May 30, 2026
- FDA UDI 4b34b60d-6a06-44c6-b26e-35f601a99140 33 fields · synced May 30, 2026
- EUDAMED d78517dd-bbf0-48e7-972b-622971cb96bc 61 fields · synced Jul 15, 2026