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Gingival Brushes
EUDAMEDClass I (EU MDR)
Ref /Model BA01,ECOBA01A,ECOBA01B,AT01,AT01L,AT01S,ECOAT01B,BH01,ECOBH01B,DH01,DH02
Identity
- Trade Name
- Gingival Brushes EUDAMED
- Device Name
- Gingival Brushes EUDAMED
- Model / Reference
- BA01,ECOBA01A,ECOBA01B,AT01,AT01L,AT01S,ECOAT01B,BH01,ECOBH01B,DH01,DH02 EUDAMED/ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06954454000045 EUDAMED
- Basic UDI-DI
- 69544540GIBR001MM EUDAMED
- EMDN Code
- Q019006 DENTAL MATERIAL APPLICATION TIPS AND BRUSHES, SINGLE-USE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Türkiye 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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Dental material injection cannula, single-use
Gingival Brushes 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 | 69544540GIBR001MM | 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 c012e3d8-6408-4a76-905d-a91c429a7480 61 fields · synced Jun 19, 2026