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Disposable Index Sensor
EUDAMEDClass I (EU MDR)
Ref 186-0201Ref KM-001Ref B-BIS-4ARef 186-0106Ref KM-003Ref KM-001ARef 186-0200Ref 186-0212KMRef 186-0200KMRef 186-0202KMRef 186-0106MTRef 186-0201KMRef 186-0200MTRef 186-0203
Identity
- Trade Name
- Disposable Index Sensor EUDAMED
- Device Name
- Disposable Index Sensor EUDAMED
- Model / Reference
- 186-0201 EUDAMEDKM-001 EUDAMEDB-BIS-4A EUDAMED186-0106 EUDAMEDKM-003 EUDAMEDKM-001A EUDAMED186-0200 EUDAMED186-0212KM EUDAMED186-0200KM EUDAMED186-0202KM EUDAMED186-0106MT EUDAMED186-0201KM EUDAMED186-0200MT EUDAMED186-0203 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975430610102 EUDAMED06975430610003 EUDAMED06975430610072 EUDAMED06975430610089 EUDAMED06975430610041 EUDAMED06975430610010 EUDAMED06975430610096 EUDAMED06975430610218 EUDAMED06975430610171 EUDAMED06975430610195 EUDAMED06975430610140 EUDAMED06975430610188 EUDAMED06975430610157 EUDAMED06975430610133 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 (14)
- EUDAMED 9b5b4be8-4e2a-4bd7-b7ed-7b9790b65b95 61 fields · synced Sep 17, 2026
- EUDAMED 33f7ceac-e10f-40a8-91d8-49cf9341254d 61 fields · synced May 18, 2026
- EUDAMED c0535bc3-a3bd-4ad1-aa16-da29906e0f7c 61 fields · synced May 18, 2026
- EUDAMED 3abf6aba-bad0-46a6-b7d9-204f94a8726c 61 fields · synced May 18, 2026
- EUDAMED 7855da04-fb8e-4b17-8a3c-a32d62d7c1b0 61 fields · synced May 18, 2026
- EUDAMED e2665b6c-645d-46cd-91df-5f5369c8e055 61 fields · synced May 18, 2026
- EUDAMED 0f4dad40-2947-4c90-ab12-cc3e37487ff0 61 fields · synced May 19, 2026
- EUDAMED 22d2a4d7-618a-4834-9e05-8f13ec571f61 61 fields · synced Jun 20, 2026
- EUDAMED 391a807d-6fdf-4b98-ac55-b1b92b7f9398 61 fields · synced Jul 9, 2026
- EUDAMED b1a9cc3b-f6c9-4aa3-bf7a-0708aa41d1a7 61 fields · synced Jul 9, 2026
- EUDAMED d0170ce0-d5c4-4c21-8a0f-14faadefdae3 61 fields · synced Jul 12, 2026
- EUDAMED 05b8e6f3-bec3-4bcc-b25a-25e83c1a39fb 61 fields · synced Jul 14, 2026
- EUDAMED 3230df86-6647-4959-b216-111db99fa07c 61 fields · synced Jul 23, 2026
- EUDAMED 07d93a9c-a415-4975-8db8-6be4c7ecc8a3 61 fields · synced Jul 23, 2026