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Fusion™ Anterior Matrix System Kit
EUDAMEDClass I (EU MDR)
Ref AN200-MRef ANK02Ref ANK01
Identity
- Trade Name
- Fusion™ Anterior Matrix System Kit EUDAMEDFusion™ Anterior Matrix Kit EUDAMED
- Device Name
- Bands Family EUDAMED
- Model / Reference
- AN200-M EUDAMEDANK02 EUDAMEDANK01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 20810038090010 EUDAMED00810038090078 EUDAMED00810038090061 EUDAMED
- Basic UDI-DI
- 081003809BandsTFXZ EUDAMED
- EMDN Code
- Q01010401 PAPER AND GUTTA-PERCHA TIPS, MATRICES AND WEDGES FOR DENTISTRY EUDAMEDQ01010199 DENTAL RESTORATION DEVICES - OTHER 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 Matrix System Kit 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 | 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 (3)
- EUDAMED 8ae261fd-59c9-4b81-9628-ed054ca9c02b 61 fields · synced Aug 4, 2026
- EUDAMED a0bf9ec5-62f3-4c3d-941d-f695cac3312b 61 fields · synced Jul 8, 2026
- EUDAMED 64bff894-a04d-4b10-9e77-22278ec5bb4e 61 fields · synced Aug 4, 2026