Identity
- Trade Name
- Fusion™ Anterior Matrix Bands EUDAMED
- Device Name
- Bands Family EUDAMED
- Model / Reference
- AN100 EUDAMEDAN200 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10810038090006 EUDAMED10810038090013 EUDAMED
- Basic UDI-DI
- 081003809BandsTFXZ 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
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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 | 081003809BandsTFXZ | 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 (2)
- EUDAMED 36484143-2bba-4a2a-baf4-acad93755459 61 fields · synced Jul 12, 2026
- EUDAMED 96476c9d-175e-4d52-b780-a2ae48f638a6 61 fields · synced May 19, 2026