Identity
- Trade Name
- Disposable Index Sensor EUDAMED
- Device Name
- Disposable Index Sensor EUDAMED
- Model / Reference
- KM-002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975430610027 EUDAMED
- Basic UDI-DI
- 697543061KM-0019S EUDAMED
- EMDN Code
- Z12062499 BIOFEEDBACK INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Disposable Index Sensor by Hunan Kemai Technology Co., LTD — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697543061KM-0019S | Class I | Active |
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Manufacturer
- Manufacturer
- Hunan Kemai Technology Co., LTD
- EUDAMED SRN
- CN-MF-000023417
- Authorised Representative
- phoenix Medtech GmbH DE-AR-000007996
Sources (1)
- EUDAMED 6e9b4245-9199-4052-8370-2dde0f0e4241 61 fields · synced Jun 19, 2026