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OPTI CCA -TS2 Blood Gas Analyzer
EUDAMEDClass A (EU MDR)
Ref GD7046Model OPTI CRITICAL CARE ANALYZER - TS2
Identity
- Trade Name
- OPTI CCA -TS2 Blood Gas Analyzer EUDAMED
- Device Name
- OPTI CCA - TS2 EUDAMED
- Model / Reference
- OPTI CRITICAL CARE ANALYZER - TS2 EUDAMEDGD7046 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00894472000732 EUDAMED
- Basic UDI-DI
- 00894472GD704644 EUDAMED
- Direct Marketing DI
- 00894472000732 EUDAMED
- EMDN Code
- W0201040101 BLOOD GAS ANALYSERS - WITH CLASSIC PROFILE (pH, pO2, pCO2, HCT + electrolytes) EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
OPTI CCA -TS2 Blood Gas Analyzer by Opti Medical Systems Inc. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 00894472GD704644 | Class A | Active |
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Manufacturer
- Manufacturer
- OPTI Medical Systems, Inc.
- EUDAMED SRN
- US-MF-000027152
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED dda9b574-d2c1-412a-bc88-bc1651c1c375 61 fields · synced Jun 18, 2026