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HySolate Flexi Dam non latex blue, 30 pcs
EUDAMEDFDA UDIClass I (EU MDR)
Ref H09947
by Dent4You AG
Identity
- Trade Name
- HySolate Flexi Dam non latex blue, 30 pcs EUDAMEDHySolate FDA UDI
- Generic Name
- Rubber dam, non-latex FDA UDI
- Device Name
- HySolate Dental Dam EUDAMEDFlexi dam non latex blue, 30 pcs FDA UDI
- Model / Reference
- H09947 EUDAMEDFDA UDI
- Description
- Flexi dam non latex blue, 30 pcs FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07630392910781 EUDAMEDFDA UDI
- Basic UDI-DI
- 76303929DENTALDAMHZ EUDAMED
- FDA Product Code
- EIE FDA UDI
- EMDN Code
- Q019002 DENTISTRY DAMS AND HOOKS, SINGLE-USE EUDAMED
- GMDN Term
- Rubber dam, non-latex FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.6300 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
HySolate Flexi Dam non latex blue, 30 pcs by Dent4You AG — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 76303929DENTALDAMHZ | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Dent4You AG
- EUDAMED SRN
- CH-MF-000028926
- Authorised Representative
- Coltène/Whaledent GmbH + Co. KG DE-AR-000005719
Sources (2)
- EUDAMED 88692b97-cd47-42dd-8934-ea5959eb6a86 61 fields · synced Jul 25, 2026
- FDA UDI a07457f4-99b1-434c-9ec5-f9bc5b13db21 34 fields · synced May 30, 2026