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ReNiTiFeile
EUDAMEDClass IIa (EU MDR)
Ref ReNT.21.25Model ReNT.21.25 ReNiTiFeile 21mm #25Ref ReNT.31.40Model ReNT.31.40 ReNiTiFeile 31mm #40Ref ReNT.21.40Model ReNT.21.40 ReNiTiFeile 21mm #40Ref ReNT.31.50Model ReNT.31.50 ReNiTiFeile 31mm #50Ref ReNT.25.25Model ReNT.25.25 ReNiTiFeile 25mm #25Ref ReNT.25.40Model ReNT.25.40 ReNiTiFeile 25mm #40Ref ReNT.21.SETModel ReNT.21.SET ReNiTiFeile 21mm #25-50 Ref ReNT.25.SETModel ReNT.25.SET ReNiTiFeile 25mm #25-50Ref ReNT.25.50Model ReNT.25.50 ReNiTiFeile 25mm #50Ref ReNT.21.50Model ReNT.21.50 ReNiTiFeile 21mm #50
Identity
- Trade Name
- ReNiTiFeile EUDAMED
- Device Name
- ReNiTiFeile EUDAMED
- Model / Reference
- ReNT.21.25 ReNiTiFeile 21mm #25 EUDAMEDReNT.21.25 EUDAMEDReNT.31.40 ReNiTiFeile 31mm #40 EUDAMEDReNT.31.40 EUDAMEDReNT.21.40 ReNiTiFeile 21mm #40 EUDAMEDReNT.21.40 EUDAMEDReNT.31.50 ReNiTiFeile 31mm #50 EUDAMEDReNT.31.50 EUDAMEDReNT.25.25 ReNiTiFeile 25mm #25 EUDAMEDReNT.25.25 EUDAMEDReNT.25.40 ReNiTiFeile 25mm #40 EUDAMEDReNT.25.40 EUDAMEDReNT.21.SET ReNiTiFeile 21mm #25-50 EUDAMEDReNT.21.SET EUDAMEDReNT.25.SET ReNiTiFeile 25mm #25-50 EUDAMEDReNT.25.SET EUDAMEDReNT.25.50 ReNiTiFeile 25mm #50 EUDAMEDReNT.25.50 EUDAMEDReNT.21.50 ReNiTiFeile 21mm #50 EUDAMEDReNT.21.50 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942512511787 EUDAMED06942512511862 EUDAMED06942512511794 EUDAMED06942512511855 EUDAMED06942512511824 EUDAMED06942512511831 EUDAMED06942512511770 EUDAMED06942512511817 EUDAMED06942512511800 EUDAMED06942512511763 EUDAMED
- Basic UDI-DI
- B-06942512511787 EUDAMEDB-06942512511862 EUDAMEDB-06942512511794 EUDAMEDB-06942512511855 EUDAMEDB-06942512511824 EUDAMEDB-06942512511831 EUDAMEDB-06942512511770 EUDAMEDB-06942512511817 EUDAMEDB-06942512511800 EUDAMEDB-06942512511763 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
ReNiTiFeile 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-06942512511787 | 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 (10)
- EUDAMED a8e329c2-0677-45bb-9695-6f66903afabb 61 fields · synced Jul 29, 2026
- EUDAMED 664c005a-dccd-48d3-84b6-75d799367c0a 61 fields · synced May 16, 2026
- EUDAMED ce8c08a8-262a-42a4-89e7-f5aa8e2e379f 61 fields · synced May 17, 2026
- EUDAMED 4c0bfea0-8b6e-47b5-bd76-8a6366e7350b 61 fields · synced May 17, 2026
- EUDAMED 9d2709cb-e98b-4ce2-bb71-c3c99c83d6dc 61 fields · synced May 17, 2026
- EUDAMED 897dd927-b844-450d-a1d3-21fe32015dea 61 fields · synced May 17, 2026
- EUDAMED fbc678c3-0f62-4822-9bef-c58443899cb3 61 fields · synced May 18, 2026
- EUDAMED 22d277b2-0ea1-4167-aba3-71075c635a34 61 fields · synced May 18, 2026
- EUDAMED 92cd29e3-5f8a-4673-b835-50fee0c5ee05 61 fields · synced May 18, 2026
- EUDAMED 2583ba43-bb3e-444b-a3d5-d467d6940b38 61 fields · synced May 19, 2026