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Primary Files
EUDAMEDClass IIa (EU MDR)
Ref D-P.01.07-019-04-040-BU-000-00-00Model Primary Files 19mm 40#04 4pcs/pack
Identity
- Trade Name
- Primary Files EUDAMED
- Device Name
- Primary Files EUDAMED
- Model / Reference
- Primary Files 19mm 40#04 4pcs/pack EUDAMEDD-P.01.07-019-04-040-BU-000-00-00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970514918242 EUDAMED
- Basic UDI-DI
- B-06970514918242 EUDAMED
- EMDN Code
- Q010507 ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Türkiye 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
Primary 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-06970514918242 | 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 (1)
- EUDAMED 5b66b20d-0a44-44e1-9326-5ac877c48007 61 fields · synced Jun 18, 2026