Identity
- Device Name
- Blood Gas Analyzer EUDAMED
- Model / Reference
- EN102 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975022535004 EUDAMED
- Basic UDI-DI
- 69750225320111CEJ7 EUDAMED
- EMDN Code
- W0201040102 BLOOD GAS ANALYSERS - WITH ADDITIONAL PARAMETERS (pH, pO2, pCO2, Hct + metabolites + electrolytes, CO-oximeter parameters and coagulation parameters) 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
Blood Gas Analyzer by Eaglenos Sciences, 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 | 69750225320111CEJ7 | Class A | Active |
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Manufacturer
- Manufacturer
- Eaglenos Sciences, Inc.
- EUDAMED SRN
- CN-MF-000036801
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (1)
- EUDAMED 4fdf4674-37f9-48a7-b6f9-f558a17f7ac6 61 fields · synced Jun 18, 2026