Identity
- Trade Name
- ProxyStrip EUDAMED
- Device Name
- Diamantstreifen EUDAMED
- Model / Reference
- FSG-1 EUDAMEDFS5-SFKP EUDAMEDFS5-XKP EUDAMED
Identifiers
- Primary DI / UDI-DI
- +E310FSG11 EUDAMED+E310FS5SFKP1 EUDAMED+E310FS5XKP1 EUDAMED
- Basic UDI-DI
- ++E310DiaStFuellDF EUDAMED
- Unit of Use DI
- +E310FS5SFKP0 EUDAMED+E310FS5XKP0 EUDAMED
- EMDN Code
- L159019 DENTAL FINISHING RASPS AND FILES, REUSABLE 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
ProxyStrip by NTI - Kahla GmbH Rotary Dental Instruments — 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 | ++E310DiaStFuellDF | Class I | Active |
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Manufacturer
- Manufacturer
- NTI-Kahla GmbH Rotary Dental Instruments
- EUDAMED SRN
- DE-MF-000009451
Sources (3)
- EUDAMED c600c9e8-80c3-4666-9317-cd23d3b397b9 61 fields · synced Oct 6, 2026
- EUDAMED 50189549-aff8-42d0-a461-6c2e6f73bf16 61 fields · synced May 17, 2026
- EUDAMED d5ee80a0-3c78-4b6b-83bb-b32d8a8c5191 61 fields · synced May 18, 2026