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Controls
EUDAMEDClass IVD General (EU MDR)
Ref Blood Gas and Electrolyte Control Level 1
Identity
- Trade Name
- Controls EUDAMED
- Device Name
- Controls EUDAMED
- Model / Reference
- Blood Gas and Electrolyte Control Level 1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06944413815544 EUDAMED
- Basic UDI-DI
- B-06944413815544 EUDAMED
- EMDN Code
- W0101050204 ELECTROLYTE CONTROLS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Special Device Type
- -1202 EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Controls by Edan Instruments, Inc. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06944413815544 | Class IVD General | 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 (1)
- EUDAMED 84682479-e164-4fb9-88b2-f712c06f5e32 61 fields · synced May 23, 2026