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Composite Polisher for Dental
EUDAMEDClass I (EU MDR)
Ref PS11AModel 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 EUDAMEDPS11A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06954454013076 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
Category: Dental appliance fabrication material, ceramic
Composite Polisher for Dental by Huanghua Promisee Dental Co.Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 6038e1b6-c954-4de7-9a3d-2e905c0bd924 61 fields · synced Jun 19, 2026