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HySolate SyntX Dam non-latex blue medium 5''x 5'' (127 x 127 mm), 30 pcs
EUDAMEDClass I (EU MDR)
Ref 60037566
by Dent4You AG
Identity
- Trade Name
- HySolate SyntX Dam non-latex blue medium 5''x 5'' (127 x 127 mm), 30 pcs EUDAMED
- Device Name
- HySolate Dental Dam EUDAMED
- Model / Reference
- 60037566 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07630392912112 EUDAMED
- Basic UDI-DI
- 76303929DENTALDAMHZ 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 SyntX Dam non-latex blue medium 5''x 5'' (127 x 127 mm), 30 pcs 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 | 76303929DENTALDAMHZ | 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 de1728b8-bf7e-4a8c-ae7e-f7cdb4a2cff2 61 fields · synced Jul 19, 2026