Identity
- Device Name
- Dental Cleanner Tablet EUDAMED
- Model / Reference
- K61280 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971739736284 EUDAMED
- Basic UDI-DI
- 697173973K61280ACK EUDAMED
- EMDN Code
- D0801 ENZYMATIC DETERGENTS FOR MEDICAL DEVICES 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
Dental Cleanner Tablet by Weifang Kaililai Chemical 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 | 697173973K61280ACK | Class I | Active |
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Manufacturer
- Manufacturer
- Weifang Kaililai Chemical Co., Ltd.
- EUDAMED SRN
- CN-MF-000044911
- Authorised Representative
- Transmed global consulting S.L. ES-AR-000044598
Sources (1)
- EUDAMED e55e2894-3a69-4cbb-877d-4f9bbe25b446 61 fields · synced Jun 19, 2026