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Denture Box
EUDAMEDClass I (EU MDR)
Ref DB07Model DB01,DB02,DB03,DB04,DB05,DB06,DB07,DB08,DB09,DB10,DB11,DB12,DB13,DB15,DB17,DB20,DB14,DB14B,DB16
Identity
- Trade Name
- Denture Box EUDAMED
- Device Name
- Denture Box EUDAMED
- Model / Reference
- DB01,DB02,DB03,DB04,DB05,DB06,DB07,DB08,DB09,DB10,DB11,DB12,DB13,DB15,DB17,DB20,DB14,DB14B,DB16 EUDAMEDDB07 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06954454000434 EUDAMED
- Basic UDI-DI
- 69544540DEBO001HR EUDAMED
- EMDN Code
- Q0199 ODONTOLOGY DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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 Box by Huanghua Promisee Dental 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 | 69544540DEBO001HR | Class I | Active |
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Manufacturer
- Manufacturer
- Huanghua Promisee Dental Co.Ltd.
- EUDAMED SRN
- CN-MF-000014766
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED 4edccc03-16fe-4358-837d-9ec99d69356a 61 fields · synced Jun 19, 2026