Identity
- Trade Name
- Denture bath EUDAMED
- Device Name
- Denture bath EUDAMED
- Model / Reference
- HEA189 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976057821704 EUDAMED
- Basic UDI-DI
- 69760578217YT EUDAMED
- EMDN Code
- Y0999 PERSONAL CARE AIDS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland 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
Denture bath by Ningbo Unico Products 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 | 69760578217YT | Class I | Active |
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Manufacturer
- Manufacturer
- Ningbo Unico Products Co., Ltd
- EUDAMED SRN
- CN-MF-000039604
- Authorised Representative
- Everbiz GmbH DE-AR-000008964
Sources (1)
- EUDAMED a1d7f0a2-a819-48b4-abdd-e0fa94f5f086 61 fields · synced Jun 18, 2026