Identity
- Device Name
- Semi-auto Electrolyte Analyzer EUDAMED
- Model / Reference
- M900 EUDAMED/ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975200380013 EUDAMED
- Basic UDI-DI
- 697520038M900DF EUDAMED
- Direct Marketing DI
- 06975200380013 EUDAMED
- EMDN Code
- W0201040201 ION SELECTIVE ELECTROLYTE ANALYSERS EUDAMED
Classification
- Device Class
- Class A 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
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Semi-auto Electrolyte Analyzer by Shenzhen Xilaiheng Medical Electronics Co., Ltd. — 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 | 697520038M900DF | Class A | Active |
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Manufacturer
- Manufacturer
- Shenzhen Xilaiheng Medical Electronics Co., Ltd.
- EUDAMED SRN
- CN-MF-000047090
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED cf59931d-2308-4bba-a7b1-4fe02b8a88fe 61 fields · synced Jun 18, 2026