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Blood Gas and Chemistry Analyzer
EUDAMEDClass A (EU MDR)
Ref i15AModel i15Ref i5009
Identity
- Trade Name
- Blood Gas and Chemistry Analyzer EUDAMED
- Device Name
- Blood Gas and Chemistry Analyzer EUDAMED
- Model / Reference
- i15 EUDAMEDi15A EUDAMEDi5009 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06944413802322 EUDAMED06944413827141 EUDAMED
- Basic UDI-DI
- 69444138i15SVA EUDAMED69444138i500SRR 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
Blood Gas and Chemistry Analyzer by Edan Instruments, 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 | 69444138i15SVA | Class A | Active |
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Manufacturer
- Manufacturer
- Edan Instruments, Inc.
- EUDAMED SRN
- CN-MF-000009957
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED 5cf4ee0e-f373-42eb-980c-26b1b988bda1 61 fields · synced Jul 29, 2026
- EUDAMED 6a486eee-67c4-4be0-b20c-988c9ffd1bd1 61 fields · synced May 18, 2026