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NiTi Files Gold
EUDAMEDClass IIa (EU MDR)
Ref CODE0831ASSTModel E08 NiTi Files Gold 4s 31mm Asst.Ref CODE08212507Model E08 NiTi Files Gold 4s 21mm No.25/07Ref CODE08253506Model E08 NiTi Files Gold 4s 25mm No.35/06Ref CODE08254505Model E08 NiTi Files Gold 4s 25mm No.45/05Ref CODE08213506Model E08 NiTi Files Gold 4s 21mm No.35/06Ref CODE08312007Model E08 NiTi Files Gold 4s 31mm No. 20/07Ref CODE08214505Model E08 NiTi Files Gold 4s 21mm No.45/05Ref CODE08252007Model E08 NiTi Files Gold 4s 25mm No.20/07Ref CODE0821ASSTModel E08 NiTi Files Gold 4s 21mm Asst.Ref CODE08252507Model E08 NiTi Files Gold 4s 25mm No.25/07
Identity
- Trade Name
- NiTi Files Gold EUDAMED
- Device Name
- Dental Root Canal Instruments Files EUDAMED
- Model / Reference
- E08 NiTi Files Gold 4s 31mm Asst. EUDAMEDCODE0831ASST EUDAMEDE08 NiTi Files Gold 4s 21mm No.25/07 EUDAMEDCODE08212507 EUDAMEDE08 NiTi Files Gold 4s 25mm No.35/06 EUDAMEDCODE08253506 EUDAMEDE08 NiTi Files Gold 4s 25mm No.45/05 EUDAMEDCODE08254505 EUDAMEDE08 NiTi Files Gold 4s 21mm No.35/06 EUDAMEDCODE08213506 EUDAMEDE08 NiTi Files Gold 4s 31mm No. 20/07 EUDAMEDCODE08312007 EUDAMEDE08 NiTi Files Gold 4s 21mm No.45/05 EUDAMEDCODE08214505 EUDAMEDE08 NiTi Files Gold 4s 25mm No.20/07 EUDAMEDCODE08252007 EUDAMEDE08 NiTi Files Gold 4s 21mm Asst. EUDAMEDCODE0821ASST EUDAMEDE08 NiTi Files Gold 4s 25mm No.25/07 EUDAMEDCODE08252507 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942512503713 EUDAMED06942512503591 EUDAMED06942512503652 EUDAMED06942512503669 EUDAMED06942512503607 EUDAMED06942512503683 EUDAMED06942512503614 EUDAMED06942512503638 EUDAMED06942512503621 EUDAMED06942512503645 EUDAMED
- Basic UDI-DI
- B-06942512503713 EUDAMEDB-06942512503591 EUDAMEDB-06942512503652 EUDAMEDB-06942512503669 EUDAMEDB-06942512503607 EUDAMEDB-06942512503683 EUDAMEDB-06942512503614 EUDAMEDB-06942512503638 EUDAMEDB-06942512503621 EUDAMEDB-06942512503645 EUDAMED
- EMDN Code
- Q010507 ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
No
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
NiTi Files Gold 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-06942512503713 | 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 4b10c6eb-1424-4a34-a539-0297a406c0b8 61 fields · synced Jul 29, 2026
- EUDAMED 754943be-2a2c-40ef-a3bc-86e65b7bb476 61 fields · synced May 16, 2026
- EUDAMED 857d1dc7-a050-40d4-a379-5796c29c282d 61 fields · synced May 17, 2026
- EUDAMED 7d4791b9-a4a0-4010-80cb-2bb44d46ead2 61 fields · synced May 17, 2026
- EUDAMED 42916d10-3270-4cc4-b71e-ca8f80674da9 61 fields · synced May 17, 2026
- EUDAMED b3230600-1585-4839-a9e9-217247089a65 61 fields · synced May 18, 2026
- EUDAMED 71cc4e2c-0139-44fe-b4df-c14e5f34496b 61 fields · synced May 18, 2026
- EUDAMED 91fee6ba-815b-4d39-b6bb-a31285b84b76 61 fields · synced May 18, 2026
- EUDAMED 951ff56c-618b-49c1-986f-b0bf672c18a2 61 fields · synced May 18, 2026
- EUDAMED 32b5b716-e611-42e0-a005-db8f8363e441 61 fields · synced May 18, 2026