← Back to catalogue
NiTi Ultrasonic Files
EUDAMEDClass IIa (EU MDR)
Ref CODE0425Model E04 NiTi Ultrasonic Files 6s 33mm No.25Ref CODE0415Model E04 NiTi Ultrasonic Files 6s 33mm No.15
Identity
- Trade Name
- NiTi Ultrasonic Files EUDAMED
- Device Name
- Dental Root Canal Instruments Files EUDAMED
- Model / Reference
- E04 NiTi Ultrasonic Files 6s 33mm No.25 EUDAMEDCODE0425 EUDAMEDE04 NiTi Ultrasonic Files 6s 33mm No.15 EUDAMEDCODE0415 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942512503201 EUDAMED06942512503188 EUDAMED
- Basic UDI-DI
- B-06942512503201 EUDAMEDB-06942512503188 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 Ultrasonic Files 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-06942512503201 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shenzhen Denco Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000014271
- Authorised Representative
- Share info GmbH DE-AR-000005132
Sources (2)
- EUDAMED c7980447-e5b4-45dd-88cf-c5931a29157a 61 fields · synced Jul 24, 2026
- EUDAMED 305d4a52-e9ae-4f3c-ab00-e553e7099723 61 fields · synced May 19, 2026