Identity
- Trade Name
- Denture cleanser EUDAMED
- Device Name
- Denture cleanser EUDAMED
- Model / Reference
- 1.7g/tablet EUDAMED2.5g/tablet EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977875160167 EUDAMED06977875160150 EUDAMED
- Basic UDI-DI
- 697787516006RW EUDAMED697787516008S2 EUDAMED
- Direct Marketing DI
- 06977875160167 EUDAMED06977875160150 EUDAMED
- EMDN Code
- Q019006 DENTAL MATERIAL APPLICATION TIPS AND BRUSHES, SINGLE-USE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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 material injection cannula, single-use
Denture cleanser by Yangzhou Sinje Biotechnology 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 | 697787516006RW | Class I | Active |
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Manufacturer
- Manufacturer
- Yangzhou Sinje Biotechnology Co., Ltd
- EUDAMED SRN
- CN-MF-000045841
- Authorised Representative
- REP Europe GmbH DE-AR-000025090
Sources (2)
- EUDAMED c6740504-9cc7-4aac-997b-8212a88f4ee6 61 fields · synced Jul 27, 2026
- EUDAMED c57120f6-7e86-467a-8c03-5e09fd012e6f 61 fields · synced May 19, 2026