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Fusion™ Anterior Wedges
EUDAMEDClass I (EU MDR)
Ref ANK4Ref ANBLRef ANK4-MRef ANYL-MRef ANOR-MRef ANGRRef ANYL
Identity
- Trade Name
- Fusion™ Anterior Wedges EUDAMED
- Device Name
- Wedges Family EUDAMED
- Model / Reference
- ANK4 EUDAMEDANBL EUDAMEDANK4-M EUDAMEDANYL-M EUDAMEDANOR-M EUDAMEDANGR EUDAMEDANYL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00810038090092 EUDAMED10810038090037 EUDAMED00810038090108 EUDAMED20810038090027 EUDAMED20810038090041 EUDAMED10810038090051 EUDAMED10810038090020 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 |
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Manufacturer
- Manufacturer
- Garrison Dental Solutions LLC
- EUDAMED SRN
- US-MF-000004112
- Authorised Representative
- Eurolink Europe Compliance Limited IE-AR-000002852
Sources (7)
- EUDAMED 782685e1-1cf6-4b9a-9b0d-0aced76d3cf5 61 fields · synced Jul 27, 2026
- EUDAMED aa7e40f8-fa17-423a-af2b-e2c7b5417bee 61 fields · synced May 17, 2026
- EUDAMED 633a070e-a614-4593-9b61-161294558bf3 61 fields · synced May 17, 2026
- EUDAMED c8215c50-f528-4ea1-b177-3bfb23d193ee 61 fields · synced May 18, 2026
- EUDAMED f766817c-131a-4fd3-a603-3b36ac129101 61 fields · synced May 18, 2026
- EUDAMED a02d4c95-92c2-4d61-b719-c69e0407ee27 61 fields · synced May 18, 2026
- EUDAMED d1511c2f-0c8d-4880-a891-b1fc35941ede 61 fields · synced May 19, 2026