Identity
- Trade Name
- edelweiss VENEER SET 43-33 S low EUDAMEDFDA UDI
- Generic Name
- Dental composite resin FDA UDI
- Device Name
- Veneer EUDAMEDSET of total 6 pcs VENEERS (1x edelweiss VENEER 43 S, 1x edelweiss VENEER 42 S, 1x edelweiss VENEER 41 S, 1x edelweiss VENEER 31 S, 1x edelweiss VENEER 32 S and 1x edelweiss VENEER 33 S) FDA UDI
- Model / Reference
- 10130 EUDAMEDFDA UDI
- Description
- SET of total 6 pcs VENEERS (1x edelweiss VENEER 43 S, 1x edelweiss VENEER 42 S, 1x edelweiss VENEER 41 S, 1x edelweiss VENEER 31 S, 1x edelweiss VENEER 32 S and 1x edelweiss VENEER 33 S) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 09120046322209 EUDAMEDFDA UDI
- Basic UDI-DI
- 912004632VeneerWP EUDAMED
- FDA Product Code
- EBF FDA UDI
- EMDN Code
- Q01020502 PRE-FORMED DENTAL CROWNS EUDAMED
- GMDN Term
- Dental composite resin 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 SET 43-33 S low 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 2815a765-96b8-4186-a9a6-d75d08bc5a21 61 fields · synced Jun 19, 2026
- FDA UDI 13a7dc8f-876c-4cb7-9a3f-6da8175f3759 33 fields · synced May 30, 2026