Identity
- Trade Name
- Y-Kelin EUDAMED
- Device Name
- Dental Appliance Cleansers EUDAMED
- Model / Reference
- 2.7 g/piece EUDAMED30 tablets/box EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06943566104550 EUDAMED
- Basic UDI-DI
- 69435661Denture004S4 EUDAMED
- EMDN Code
- Q010599 DENTAL INSTRUMENTS, SINGLE-USE - 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
Y-Kelin by Anhui Greenland Biotech 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 | 69435661Denture004S4 | Class I | Active |
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Manufacturer
- Manufacturer
- Anhui Greenland Biotech Co., Ltd
- EUDAMED SRN
- CN-MF-000026195
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED fc55342e-af68-4ab7-a507-c6842a228e17 61 fields · synced May 25, 2026