Identity
- Trade Name
- edelweiss VENEER 11/21 M EUDAMEDFDA UDI
- Generic Name
- Dental veneer, professional FDA UDI
- Device Name
- Veneer EUDAMEDSet of 1x edelweiss VENEER 11 M and 1x edelweiss VENEER 21 M FDA UDI
- Model / Reference
- 10181 EUDAMEDFDA UDI
- Description
- Set of 1x edelweiss VENEER 11 M and 1x edelweiss VENEER 21 M FDA UDI
Identifiers
- Primary DI / UDI-DI
- 09120046320649 EUDAMEDFDA UDI
- Basic UDI-DI
- 912004632VeneerWP EUDAMED
- FDA Product Code
- EBF FDA UDI
- EMDN Code
- Q01020502 PRE-FORMED DENTAL CROWNS EUDAMED
- GMDN Term
- Dental veneer, professional FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3690 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
edelweiss VENEER 11/21 M by Edelweiss Dentistry Products Gmbh — Class IIa — 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 | 912004632VeneerWP | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- edelweiss dentistry products gmbh
- EUDAMED SRN
- AT-MF-000005413
Sources (2)
- EUDAMED 390240c3-0d9f-4ccd-b22f-dec9801dc463 61 fields · synced Jun 18, 2026
- FDA UDI d6f97a39-e305-43b3-9149-9bb94a7206a3 33 fields · synced May 30, 2026