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Dental Wedge
EUDAMEDClass I (EU MDR)
Ref /Model PW01,PW01L,PW01M,PW01S,PW01SS,PW02,PW02L,PW02M,PW02S,PW02SS,PW03,PW04,PW04L,PW04M,PW04S,PW05,PW05L,PW05M,PW05S,PW06,PW06L,PW06S,PW07,PW07L,PW07M,PW07S,WG01,WG01L,WG01M,WG01S,SC0301,RD09
Identity
- Trade Name
- Dental Wedge EUDAMED
- Device Name
- Dental Wedge EUDAMED
- Model / Reference
- PW01,PW01L,PW01M,PW01S,PW01SS,PW02,PW02L,PW02M,PW02S,PW02SS,PW03,PW04,PW04L,PW04M,PW04S,PW05,PW05L,PW05M,PW05S,PW06,PW06L,PW06S,PW07,PW07L,PW07M,PW07S,WG01,WG01L,WG01M,WG01S,SC0301,RD09 EUDAMED/ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06954454001585 EUDAMED
- Basic UDI-DI
- 69544540DEWE001NS EUDAMED
- EMDN Code
- Q01010401 PAPER AND GUTTA-PERCHA TIPS, MATRICES AND WEDGES FOR DENTISTRY EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
Yes
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
Dental Wedge 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 | 69544540DEWE001NS | 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 56edc0b5-c70d-435a-a14b-20750b5fc670 61 fields · synced Jun 18, 2026