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ReFlex Feile
EUDAMEDClass IIa (EU MDR)
Ref ReFlex.31.40Model ReFlex.31.40 ReFlex Feile 31mm #40Ref ReFlex.25.40Model ReFlex.25.40 ReFlex Feile 25mm #40Ref ReFlex.31.SETModel ReFlex.31.SET ReFlex Feile 31mm #25-50Ref ReFlex.21.40Model ReFlex.21.40 ReFlex Feile 21mm #40Ref ReFlex.25.SETModel ReFlex.25.SET ReFlex Feile 25mm #25-50Ref ReFlex.21.SETModel ReFlex.21.SET ReFlex Feile 21mm #25-50Ref ReFlex.31.50Model ReFlex.31.50 ReFlex Feile 31mm #50Ref ReFlex.21.25Model ReFlex.21.25 ReFlex Feile 21mm #25
Identity
- Trade Name
- ReFlex Feile EUDAMED
- Device Name
- ReFlex Feile EUDAMED
- Model / Reference
- ReFlex.31.40 ReFlex Feile 31mm #40 EUDAMEDReFlex.31.40 EUDAMEDReFlex.25.40 ReFlex Feile 25mm #40 EUDAMEDReFlex.25.40 EUDAMEDReFlex.31.SET ReFlex Feile 31mm #25-50 EUDAMEDReFlex.31.SET EUDAMEDReFlex.21.40 ReFlex Feile 21mm #40 EUDAMEDReFlex.21.40 EUDAMEDReFlex.25.SET ReFlex Feile 25mm #25-50 EUDAMEDReFlex.25.SET EUDAMEDReFlex.21.SET ReFlex Feile 21mm #25-50 EUDAMEDReFlex.21.SET EUDAMEDReFlex.31.50 ReFlex Feile 31mm #50 EUDAMEDReFlex.31.50 EUDAMEDReFlex.21.25 ReFlex Feile 21mm #25 EUDAMEDReFlex.21.25 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942512512081 EUDAMED06942512512074 EUDAMED06942512512111 EUDAMED06942512512029 EUDAMED06942512512050 EUDAMED06942512512036 EUDAMED06942512512098 EUDAMED06942512512005 EUDAMED
- Basic UDI-DI
- B-06942512512081 EUDAMEDB-06942512512074 EUDAMEDB-06942512512111 EUDAMEDB-06942512512029 EUDAMEDB-06942512512050 EUDAMEDB-06942512512036 EUDAMEDB-06942512512098 EUDAMEDB-06942512512005 EUDAMED
- EMDN Code
- Q010507 ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
ReFlex Feile by Shenzhen Denco Medical Co., Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06942512512081 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shenzhen Denco Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000014271
- Authorised Representative
- Share info GmbH DE-AR-000005132
Sources (8)
- EUDAMED 061329b1-d3f8-4d50-bc0e-8bd3d06f413f 61 fields · synced Oct 1, 2026
- EUDAMED e55fb141-1aab-4e1e-ae78-edadf4a05736 61 fields · synced May 16, 2026
- EUDAMED 4e6e30af-cfcf-41ae-a303-27c6caff527f 61 fields · synced May 17, 2026
- EUDAMED 579c5c67-1ea6-4108-a622-852349c79248 61 fields · synced May 17, 2026
- EUDAMED bf34ea8e-ad8b-4795-886f-e8ec3518eddf 61 fields · synced May 18, 2026
- EUDAMED b8daf950-288b-4fa1-8cf9-08b0e28c2450 61 fields · synced May 18, 2026
- EUDAMED 891f28d2-85aa-4f5b-b8c2-1552a39f0f4b 61 fields · synced May 18, 2026
- EUDAMED cd82d4fb-4803-4e06-8913-dfc78bdcafc3 61 fields · synced May 18, 2026