Identity
- Trade Name
- Nu:le Coat Gum Set EUDAMED
- Device Name
- Nu:le Coat EUDAMED
- Model / Reference
- Dental Resin EUDAMEDNu:le Coat EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04570110515245 EUDAMED
- Basic UDI-DI
- 456023117D10B103N001V6 EUDAMED
- EMDN Code
- Q010299 PROSTHETIC DENTISTRY DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Romania 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
Nu:le Coat Gum Set by Yamakin Co., Ltd. — Class IIa — 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 | 456023117D10B103N001V6 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Yamakin Co., Ltd.
- EUDAMED SRN
- JP-MF-000011382
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (1)
- EUDAMED 424b726d-6819-4669-9d39-bca66ba72876 61 fields · synced Jul 31, 2026