Identity
- Trade Name
- Fusion™ Anterior Wedges EUDAMED
- Device Name
- Wedges Family EUDAMED
- Model / Reference
- ANGR-M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 20810038090058 EUDAMED
- Basic UDI-DI
- 081003809WedgesTFZH EUDAMED
- EMDN Code
- Q01010401 PAPER AND GUTTA-PERCHA TIPS, MATRICES AND WEDGES FOR DENTISTRY 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
Fusion™ Anterior Wedges by Garrison Dental Solutions LLC — 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 | 081003809WedgesTFZH | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Garrison Dental Solutions LLC
- EUDAMED SRN
- US-MF-000004112
- Authorised Representative
- Eurolink Europe Compliance Limited IE-AR-000002852
Sources (1)
- EUDAMED 3327a20e-a9eb-4707-ad63-e9cfb4a0b637 61 fields · synced Jun 18, 2026