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Endo Files
EUDAMEDClass I (EU MDR)
Ref Reamers:S1Model K-Files; H-Files; Reamers; Pesso reamers; Gate drills; Barbed broaches; Paste carriersRef Paste carriers:35#Ref Reamers:45-80#Ref Reamers:SXRef Barbed broaches:1-6#Ref H-Files: 20#Ref H-Files: 35#Ref H-Files: 70#Ref Barbed broaches:6#Ref Gate drills:3#Ref Reamers:F3Ref Pesso reamers:4#Ref Gate drills:6#Ref Reamers:30#Ref H-Files: 15-40#Ref K-Files: 20#Ref K-Files: 55#Ref Reamers:8#Ref Gate drills:2#Ref Reamers:70#Ref H-Files: 45#Ref K-Files: 35#Ref K-Files: 60#Ref Reamers:SX-F3Ref K-Files: 45-80#Ref K-Files: 50#Ref Reamers:S2Ref Reamers:10#Ref H-Files: 60#Ref Pesso reamers:2#Ref Reamers:55#Ref Barbed broaches:2#Ref Barbed broaches:00#Ref Barbed broaches:3#Ref Gate drills:5#Ref H-Files: 80#Ref K-Files: 45#Ref Paste carriers:40#Ref Pesso reamers:3#Ref Pesso reamers:6#Ref K-Files: 15-40#Ref K-Files: 80#Ref Barbed broaches:1#Ref K-Files: 70#Ref Reamers:80#Ref Paste carriers:25#-40#Ref Barbed broaches:4#Ref Reamers:15-40#Ref K-Files: 30#
Identity
- Device Name
- Endo Files EUDAMED
- Model / Reference
- K-Files; H-Files; Reamers; Pesso reamers; Gate drills; Barbed broaches; Paste carriers EUDAMEDReamers:S1 EUDAMEDPaste carriers:35# EUDAMEDReamers:45-80# EUDAMEDReamers:SX EUDAMEDBarbed broaches:1-6# EUDAMEDH-Files: 20# EUDAMEDH-Files: 35# EUDAMEDH-Files: 70# EUDAMEDBarbed broaches:6# EUDAMEDGate drills:3# EUDAMEDReamers:F3 EUDAMEDPesso reamers:4# EUDAMEDGate drills:6# EUDAMEDReamers:30# EUDAMEDH-Files: 15-40# EUDAMEDK-Files: 20# EUDAMEDK-Files: 55# EUDAMEDReamers:8# EUDAMEDGate drills:2# EUDAMEDReamers:70# EUDAMEDH-Files: 45# EUDAMEDK-Files: 35# EUDAMEDK-Files: 60# EUDAMEDReamers:SX-F3 EUDAMEDK-Files: 45-80# EUDAMEDK-Files: 50# EUDAMEDReamers:S2 EUDAMEDReamers:10# EUDAMEDH-Files: 60# EUDAMEDPesso reamers:2# EUDAMEDReamers:55# EUDAMEDBarbed broaches:2# EUDAMEDBarbed broaches:00# EUDAMEDBarbed broaches:3# EUDAMEDGate drills:5# EUDAMEDH-Files: 80# EUDAMEDK-Files: 45# EUDAMEDPaste carriers:40# EUDAMEDPesso reamers:3# EUDAMEDPesso reamers:6# EUDAMEDK-Files: 15-40# EUDAMEDK-Files: 80# EUDAMEDBarbed broaches:1# EUDAMEDK-Files: 70# EUDAMEDReamers:80# EUDAMEDPaste carriers:25#-40# EUDAMEDBarbed broaches:4# EUDAMEDReamers:15-40# EUDAMEDK-Files: 30# EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978256550621 EUDAMED06978256550942 EUDAMED06978256550607 EUDAMED06978256550614 EUDAMED06978256550911 EUDAMED06978256550300 EUDAMED06978256550331 EUDAMED06978256550409 EUDAMED06978256550904 EUDAMED06978256550775 EUDAMED06978256550669 EUDAMED06978256550713 EUDAMED06978256550805 EUDAMED06978256550508 EUDAMED06978256550355 EUDAMED06978256550140 EUDAMED06978256550225 EUDAMED06978256550454 EUDAMED06978256550768 EUDAMED06978256550584 EUDAMED06978256550362 EUDAMED06978256550171 EUDAMED06978256550232 EUDAMED06978256550676 EUDAMED06978256550263 EUDAMED06978256550218 EUDAMED06978256550638 EUDAMED06978256550461 EUDAMED06978256550393 EUDAMED06978256550690 EUDAMED06978256550560 EUDAMED06978256550867 EUDAMED06978256550836 EUDAMED06978256550874 EUDAMED06978256550799 EUDAMED06978256550416 EUDAMED06978256550201 EUDAMED06978256550959 EUDAMED06978256550706 EUDAMED06978256550737 EUDAMED06978256550195 EUDAMED06978256550256 EUDAMED06978256550850 EUDAMED06978256550249 EUDAMED06978256550591 EUDAMED06978256550966 EUDAMED06978256550881 EUDAMED06978256550539 EUDAMED06978256550164 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 (49)
- EUDAMED 0ae9c3ce-1007-4f32-89d2-ad94e59a1167 61 fields · synced Oct 6, 2026
- EUDAMED 4a31ae49-90c6-4b93-8886-b203f6a06360 61 fields · synced May 11, 2026
- EUDAMED 9d8f9e4f-ecda-4ad5-b66c-7d369d7cc609 61 fields · synced May 11, 2026
- EUDAMED 8b8c304b-4ae2-487a-813c-26b364afc578 61 fields · synced May 16, 2026
- EUDAMED 6bdd3fb6-d15a-475f-b386-ac4e5da06784 61 fields · synced May 16, 2026
- EUDAMED e24d48a7-d774-431f-95e6-03c73ac18875 61 fields · synced May 16, 2026
- EUDAMED f70f23b6-6c42-4e9b-9a5b-7d62f2e0081f 61 fields · synced May 16, 2026
- EUDAMED 6a35e5a9-4063-4db1-b571-003ec2b5e75b 61 fields · synced May 16, 2026
- EUDAMED 5060bea6-1497-4556-b12a-ceda9848ccb7 61 fields · synced May 16, 2026
- EUDAMED 604c80eb-f00f-4a52-bd84-b543d483002b 61 fields · synced May 16, 2026
- EUDAMED aea32380-a34f-4004-9ee3-d68eaf1d709f 61 fields · synced May 16, 2026
- EUDAMED e313578d-b88a-4f92-8259-b488bb57d10a 61 fields · synced May 16, 2026
- EUDAMED ab3e8af7-0eff-48ff-979c-858471873a31 61 fields · synced May 16, 2026
- EUDAMED b70970f5-b7a9-4631-826b-5be23993ca92 61 fields · synced May 16, 2026
- EUDAMED 44b714f9-7714-4cdd-96d9-2d985158b429 61 fields · synced May 16, 2026
- EUDAMED 1d860e58-c64f-4fde-a9ad-132199333068 61 fields · synced May 16, 2026
- EUDAMED 8079e1d9-dbba-4c44-be17-e3cdf1753ee9 61 fields · synced May 17, 2026
- EUDAMED 6f64bda2-96f3-4451-8de5-3eff49a4abec 61 fields · synced May 17, 2026
- EUDAMED b12ef5b7-bb18-4d5d-bf48-bdba71b9d772 61 fields · synced May 17, 2026
- EUDAMED 19108d93-c0a0-42a2-9f87-23bef89d036d 61 fields · synced May 17, 2026
- EUDAMED 34334370-b396-414b-afb0-d95c64524d3a 61 fields · synced May 17, 2026
- EUDAMED 7a91622a-99f7-4e8a-9edf-131558644b9b 61 fields · synced May 17, 2026
- EUDAMED f11628ae-fd1c-4715-bca0-bfa306bb6ad5 61 fields · synced May 17, 2026
- EUDAMED 09db31cf-2317-40df-a74b-14d3a0312455 61 fields · synced May 17, 2026
- EUDAMED 17dacf19-23a6-4898-9f98-03c561759891 61 fields · synced May 17, 2026
- EUDAMED 01487915-af51-435e-a75c-fd9dc8e89e43 61 fields · synced May 17, 2026
- EUDAMED 4bfa473d-c7e4-463d-82fa-79890081d2d3 61 fields · synced May 17, 2026
- EUDAMED 771a6791-c275-45f4-a74a-6ea1826b5abb 61 fields · synced May 17, 2026
- EUDAMED 481c4713-7c61-4294-8556-1c2407334cca 61 fields · synced May 17, 2026
- EUDAMED 35577cf7-8e6a-4fcb-8150-970dc2f4615e 61 fields · synced May 17, 2026
- EUDAMED bf587241-c34f-454f-877e-8c585be4245c 61 fields · synced May 17, 2026
- EUDAMED 3f5a3d64-fdef-4976-b42e-99810e75d71f 61 fields · synced May 18, 2026
- EUDAMED 219f2364-b763-4499-bf3d-66d09d1259f7 61 fields · synced May 18, 2026
- EUDAMED b1ea5ae8-2984-490b-a76c-42e1ad3edb76 61 fields · synced May 18, 2026
- EUDAMED a2e7635f-1977-4d6a-8567-a8ac80ce3b4c 61 fields · synced May 18, 2026
- EUDAMED 519404ab-b662-4b9a-afdc-5d3775ea2041 61 fields · synced May 18, 2026
- EUDAMED 1519b407-0d37-47ff-8364-24dbaceba6ff 61 fields · synced May 18, 2026
- EUDAMED e0e57c81-c0ea-4439-97c9-edb7c1f384ec 61 fields · synced May 18, 2026
- EUDAMED 31ce05c2-7a71-4032-b02d-cc8dae97057b 61 fields · synced May 18, 2026
- EUDAMED 6d3f840c-3d84-4e25-a6f1-f0e8bda79748 61 fields · synced May 18, 2026
- EUDAMED b6e08d41-3cbc-42ed-8727-3e33bdc7a56c 61 fields · synced May 18, 2026
- EUDAMED 3d77c2a1-583e-4bdd-92f9-5244cd8cbfd7 61 fields · synced May 18, 2026
- EUDAMED 8a834314-c58a-4dde-9387-9f564ae31af9 61 fields · synced May 18, 2026
- EUDAMED 58a6ce16-ce5f-40ea-b211-6f7885f0a6e8 61 fields · synced May 19, 2026
- EUDAMED df8680be-44f8-4bc7-a202-728610c7c45c 61 fields · synced May 19, 2026
- EUDAMED e6c41713-2941-43ad-a897-f3a2b172b726 61 fields · synced May 19, 2026
- EUDAMED 3d13fc6f-e19f-487f-b539-7dc1eeb698b6 61 fields · synced May 19, 2026
- EUDAMED 6a26c6c3-1beb-4053-b573-0a01ca99ec9a 61 fields · synced May 19, 2026
- EUDAMED 9c30ff00-1824-4f71-a233-6cbda7012635 61 fields · synced May 19, 2026