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Pa-Files
EUDAMEDClass IIa (EU MDR)
Ref D-P.01.11-021-02-013-SR-000-00-00Model PA-FILES 21mm #013 6pcs/packRef D-P.01.11-031-02-019-SR-000-00-00Model PA-FILES 31mm #019 6pcs/packRef D-P.01.11-031-02-016-SR-000-00-00Model PA-FILES 31mm #016 6pcs/packRef D-P.01.11-025-02-019-SR-000-00-00Model PA-FILES 25mm #019 6pcs/packRef D-P.01.11-021-02-016-SR-000-00-00Model PA-FILES 21mm #016 6pcs/packRef D-P.01.11-025-02-0A0-SR-000-00-00Model PA-FILES 25mm #013-019 6pcs/pack
Identity
- Trade Name
- PA-FILES EUDAMED
- Device Name
- PA-FILES EUDAMED
- Model / Reference
- PA-FILES 21mm #013 6pcs/pack EUDAMEDD-P.01.11-021-02-013-SR-000-00-00 EUDAMEDPA-FILES 31mm #019 6pcs/pack EUDAMEDD-P.01.11-031-02-019-SR-000-00-00 EUDAMEDPA-FILES 31mm #016 6pcs/pack EUDAMEDD-P.01.11-031-02-016-SR-000-00-00 EUDAMEDPA-FILES 25mm #019 6pcs/pack EUDAMEDD-P.01.11-025-02-019-SR-000-00-00 EUDAMEDPA-FILES 21mm #016 6pcs/pack EUDAMEDD-P.01.11-021-02-016-SR-000-00-00 EUDAMEDPA-FILES 25mm #013-019 6pcs/pack EUDAMEDD-P.01.11-025-02-0A0-SR-000-00-00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970514911694 EUDAMED06970514913001 EUDAMED06970514912998 EUDAMED06970514912974 EUDAMED06970514912936 EUDAMED06970514910093 EUDAMED
- Basic UDI-DI
- B-06970514911694 EUDAMEDB-06970514913001 EUDAMEDB-06970514912998 EUDAMEDB-06970514912974 EUDAMEDB-06970514912936 EUDAMEDB-06970514910093 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
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-06970514911694 | 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 62789852-f6a4-45f1-b744-e9efa6810b01 61 fields · synced Jul 31, 2026
- EUDAMED ea818372-037e-488c-bbde-1f3c78e6abff 61 fields · synced May 17, 2026
- EUDAMED cbbb2afe-7dcf-47c7-8091-4cd658c966d2 61 fields · synced May 17, 2026
- EUDAMED 420c06a2-0d87-413e-90fc-f1f512419362 61 fields · synced May 18, 2026
- EUDAMED d7417986-a3fa-41e9-9f5f-14e5d973a99f 61 fields · synced May 19, 2026
- EUDAMED 7ebb722e-6f41-4985-ac7f-69e3c8bccafa 61 fields · synced May 19, 2026