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FitStrip™ Interproximal Finishing & Contouring
EUDAMEDClass I (EU MDR)
Ref FPSHANDLE-2
Identity
- Trade Name
- FitStrip™ Interproximal Finishing & Contouring EUDAMED
- Device Name
- Polishers & Abrasives Family EUDAMED
- Model / Reference
- FPSHANDLE-2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10810038093991 EUDAMED
- Basic UDI-DI
- 081003809PolishersTFAC EUDAMED
- EMDN Code
- Q010499 ORTHODONTIC 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
FitStrip™ Interproximal Finishing & Contouring 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 | 081003809PolishersTFAC | 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 dd08b7f1-7d6b-4508-9a69-26384ef6c7bc 61 fields · synced Jul 20, 2026