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Endo Files
EUDAMEDClass I (EU MDR)
Ref K-Files: 8#Model K-Files; H-Files; Reamers; Pesso reamers; Gate drills; Barbed broaches; Paste carriers
Identity
- Device Name
- Endo Files EUDAMED
- Model / Reference
- K-Files; H-Files; Reamers; Pesso reamers; Gate drills; Barbed broaches; Paste carriers EUDAMEDK-Files: 8# EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978256550119 EUDAMED
- Basic UDI-DI
- 697825655EDFVE EUDAMED
- EMDN Code
- L159019 DENTAL FINISHING RASPS AND FILES, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
Endo Files by Guangzhou Befull Medical Instruments Co., Ltd — 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 | 697825655EDFVE | Class I | Active |
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Manufacturer
- Manufacturer
- Guangzhou Befull Medical Instruments Co., Ltd
- EUDAMED SRN
- CN-MF-000050099
- Authorised Representative
- HyperCert Limited B.V. NL-AR-000047746
Sources (1)
- EUDAMED 9bc5861a-5015-4615-a30c-6ba9bc08df06 61 fields · synced Jun 18, 2026