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Endodontic Files
EUDAMEDClass IIa (EU MDR)
Ref 5181187Model E-FLEX BLUE-XXX, E-FLEX EDGE-XXX, E-FLEX GOLD-XXX, E-FLEX MINI-XXX, E-FLEX ONE-XXX, E-FLEX REC-XXX, E-FLEX S-XXX, E-FLEX-XXX, E-STYLE BLUE, E-STYLE BLUE-XXX, E-STYLE GOLD, E-STYLE GOLD-XXX
Identity
- Trade Name
- Endodontic Files EUDAMED
- Device Name
- Endodontic Files EUDAMED
- Model / Reference
- E-FLEX BLUE-XXX, E-FLEX EDGE-XXX, E-FLEX GOLD-XXX, E-FLEX MINI-XXX, E-FLEX ONE-XXX, E-FLEX REC-XXX, E-FLEX S-XXX, E-FLEX-XXX, E-STYLE BLUE, E-STYLE BLUE-XXX, E-STYLE GOLD, E-STYLE GOLD-XXX EUDAMED5181187 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975132959172 EUDAMED
- Basic UDI-DI
- 697259778EF001KX EUDAMED
- EMDN Code
- L159004 ENDODONTIC RASPS AND FILES, REUSABLE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Czechia 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
Category: Manual endodontic file/rasp, reusable
Endodontic Files by Changzhou Sifary Medical Technology Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 697259778EF001KX | Class IIa | Active |
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Manufacturer
- Manufacturer
- Changzhou Sifary Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000010405
- Authorised Representative
- Caretechion GmbH DE-AR-000005946
Sources (1)
- EUDAMED d381d4e8-a39f-4bc2-93e0-e83e00567e19 61 fields · synced Jun 19, 2026