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HySolate LAM Fiesta 9W Dental Dam Clamp Kit, 9 clamps
EUDAMEDClass I (EU MDR)
Ref 60018550
by Dent4You AG
Identity
- Trade Name
- HySolate LAM Fiesta 9W Dental Dam Clamp Kit, 9 clamps EUDAMED
- Device Name
- HySolate Clamps EUDAMED
- Model / Reference
- 60018550 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07630392901093 EUDAMED
- Basic UDI-DI
- 76303929DDCLAMPLU EUDAMED
- EMDN Code
- Q019002 DENTISTRY DAMS AND HOOKS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class I EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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 LAM Fiesta 9W Dental Dam Clamp Kit, 9 clamps 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 | 76303929DDCLAMPLU | 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 d86614cd-7f13-4c02-bd61-8952842f85d6 61 fields · synced Aug 2, 2026