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HySolate Dental Dam Template Adult (6 x 6), 1 pc
EUDAMEDClass I (EU MDR)
Ref H01441
by Dent4You AG
Identity
- Trade Name
- HySolate Dental Dam Template Adult (6 x 6), 1 pc EUDAMED
- Device Name
- HySolate Dental Dam Templates EUDAMED
- Model / Reference
- H01441 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07630392900461 EUDAMED
- Basic UDI-DI
- 76303929DDTEMPLATE7T EUDAMED
- EMDN Code
- Q019002 DENTISTRY DAMS AND HOOKS, 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
HySolate Dental Dam Template Adult (6 x 6), 1 pc by Dent4You AG — 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 | 76303929DDTEMPLATE7T | Class I | Active |
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Manufacturer
- Manufacturer
- Dent4You AG
- EUDAMED SRN
- CH-MF-000028926
- Authorised Representative
- Coltène/Whaledent GmbH + Co. KG DE-AR-000005719
Sources (1)
- EUDAMED abdb02bd-cb3a-499b-894b-8d3a3cecd80e 61 fields · synced Jun 19, 2026