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Composite Polisher for Dental
EUDAMEDClass I (EU MDR)
Ref PS10BModel PS03, PS04, PS05,PS06M,PS06F, PS07M,PS07F
Identity
- Trade Name
- Composite Polisher for Dental EUDAMED
- Device Name
- Composite Polisher for Dental EUDAMED
- Model / Reference
- PS03, PS04, PS05,PS06M,PS06F, PS07M,PS07F EUDAMEDPS10B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06954454013731 EUDAMED
- Basic UDI-DI
- 69544540COPO001S4 EUDAMED
- EMDN Code
- Q01010199 DENTAL RESTORATION 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
Composite Polisher for Dental 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 | 69544540COPO001S4 | 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 9fea72d1-6048-421d-91b6-dff221b72717 61 fields · synced Jun 19, 2026