Identity
- Device Name
- Teeth Cleaner EUDAMED
- Model / Reference
- K15, K12, K325; EUDAMED000002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978374120157 EUDAMED
- Basic UDI-DI
- 697837412K15SG EUDAMED
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain 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
Teeth Cleaner by Shenzhen Laixi electronic 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 | 697837412K15SG | Class I | Active |
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Manufacturer
- Manufacturer
- Shenzhen Laixi electronic Technology Co., LTD
- EUDAMED SRN
- CN-MF-000047051
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (1)
- EUDAMED e2b91c5d-694b-41db-98eb-c3b965190eca 61 fields · synced Jun 19, 2026