Identity
- Trade Name
- Matrix and Wedge Placement Instrument EUDAMED
- Device Name
- Instruments Family EUDAMED
- Model / Reference
- BWI EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00810038091457 EUDAMED
- Basic UDI-DI
- 081003809InstrumentsTFTF EUDAMED
- EMDN Code
- L15901101 POSITIONING INSTRUMENTS FOR DENTAL MATRICES, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Matrix and Wedge Placement Instrument 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 | 081003809InstrumentsTFTF | 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 (1)
- EUDAMED 42818821-d56b-4d7b-bc9a-a03a499964e3 61 fields · synced Oct 6, 2026