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NiTi PA Files
EUDAMEDClass IIa (EU MDR)
Ref CODE1421016Model E14 NiTi PA Files 6s 21mm No.016Ref CODE1421019Model E14 NiTi PA Files 6s 21mm No.019Ref CODE1425016Model E14 NiTi PA Files 6s 25mm No.016Ref CODE1425ASSTModel E14 NiTi PA Files 6s 25mm Asst.Ref CODE1421013Model E14 NiTi PA Files 6s 21mm No.013Ref CODE1425019Model E14 NiTi PA Files 6s 25mm No.019
Identity
- Trade Name
- NiTi PA Files EUDAMED
- Device Name
- Dental Root Canal Instruments Files EUDAMED
- Model / Reference
- E14 NiTi PA Files 6s 21mm No.016 EUDAMEDCODE1421016 EUDAMEDE14 NiTi PA Files 6s 21mm No.019 EUDAMEDCODE1421019 EUDAMEDE14 NiTi PA Files 6s 25mm No.016 EUDAMEDCODE1425016 EUDAMEDE14 NiTi PA Files 6s 25mm Asst. EUDAMEDCODE1425ASST EUDAMEDE14 NiTi PA Files 6s 21mm No.013 EUDAMEDCODE1421013 EUDAMEDE14 NiTi PA Files 6s 25mm No.019 EUDAMEDCODE1425019 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942512504239 EUDAMED06942512504246 EUDAMED06942512504277 EUDAMED06942512504291 EUDAMED06942512504222 EUDAMED06942512504284 EUDAMED
- Basic UDI-DI
- B-06942512504239 EUDAMEDB-06942512504246 EUDAMEDB-06942512504277 EUDAMEDB-06942512504291 EUDAMEDB-06942512504222 EUDAMEDB-06942512504284 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 PA 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-06942512504239 | 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 (6)
- EUDAMED 22f1bf8b-33c0-4dbd-8c97-85b797b4bba7 61 fields · synced Jul 25, 2026
- EUDAMED 22ede290-3f7a-4993-8316-0621820fbb7b 61 fields · synced May 17, 2026
- EUDAMED aa2fbf77-3e72-48e2-92c7-5ebf867ce07d 61 fields · synced May 18, 2026
- EUDAMED 83a36dc0-3b1c-465f-90b3-e7bb285d1c90 61 fields · synced May 19, 2026
- EUDAMED 98f10f05-28b4-4b98-89de-90462dc0899d 61 fields · synced May 19, 2026
- EUDAMED fcbd0968-4d71-434e-bdbd-284ae5aec899 61 fields · synced May 19, 2026