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Endodontic Files
EUDAMEDClass IIa (EU MDR)
Ref 5181680Model 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 EUDAMED5181680 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941877808969 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
Endodontic Files by Changzhou Sifary Medical Technology Co., Ltd. — Class IIa — 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 | 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 4ea1e66a-ad3c-4d7a-a912-598e0ad003ab 61 fields · synced Jun 19, 2026