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D-Files

EUDAMED

Class IIa (EU MDR)

Ref D-P.01.08-022-07-0D3-SR-000-00-00Model D-Files 22mm D3 6pcs/packRef D-P.01.08-0VL-VT-0A0-SR-000-00-00Model D-Files D1-D3 6pcs/packRef D-P.01.08-018-08-0D2-SR-000-00-00Model D-Files 18mm D2 6pcs/pack

by Shenzhen Denco Medical Co., Ltd.

Identity

Trade Name
D-Files EUDAMED
Device Name
D-Files EUDAMED
Model / Reference
D-Files 22mm D3 6pcs/pack EUDAMED
D-P.01.08-022-07-0D3-SR-000-00-00 EUDAMED
D-Files D1-D3 6pcs/pack EUDAMED
D-P.01.08-0VL-VT-0A0-SR-000-00-00 EUDAMED
D-Files 18mm D2 6pcs/pack EUDAMED
D-P.01.08-018-08-0D2-SR-000-00-00 EUDAMED

Identifiers

Primary DI / UDI-DI
06970514918174 EUDAMED
06970514911670 EUDAMED
06970514918167 EUDAMED
Basic UDI-DI
B-06970514918174 EUDAMED
B-06970514911670 EUDAMED
B-06970514918167 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

D-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

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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 (3)

  • EUDAMED d65fc165-7b55-4214-9250-5972c74583a8 61 fields · synced Aug 5, 2026
  • EUDAMED b3a3c788-e4b2-4950-a181-2f730f705417 61 fields · synced May 16, 2026
  • EUDAMED e725da66-1163-4459-b3f0-0acdd07d7376 61 fields · synced May 18, 2026