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NiTi D Files

EUDAMED

Class IIa (EU MDR)

Ref CODE1016D1Model E10 NiTi D Files 6s 16mm No.D1Ref CODE1022D3Model E10 NiTi D Files 6s 22mm No.D3Ref CODE1018D2Model E10 NiTi D Files 6s 18mm No.D2

by Shenzhen Denco Medical Co., Ltd.

Identity

Trade Name
NiTi D Files EUDAMED
Device Name
Dental Root Canal Instruments Files EUDAMED
Model / Reference
E10 NiTi D Files 6s 16mm No.D1 EUDAMED
CODE1016D1 EUDAMED
E10 NiTi D Files 6s 22mm No.D3 EUDAMED
CODE1022D3 EUDAMED
E10 NiTi D Files 6s 18mm No.D2 EUDAMED
CODE1018D2 EUDAMED

Identifiers

Primary DI / UDI-DI
06942512503942 EUDAMED
06942512503966 EUDAMED
06942512503959 EUDAMED
Basic UDI-DI
B-06942512503942 EUDAMED
B-06942512503966 EUDAMED
B-06942512503959 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 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 dc947cff-0208-46e3-a56a-80a46c8d8740 61 fields · synced Jul 28, 2026
  • EUDAMED 6f56153b-c7bb-4b5b-bbc6-70753a0f72b9 61 fields · synced May 18, 2026
  • EUDAMED 4b2ce6bb-346c-40bd-965f-8eaeec1f0982 61 fields · synced May 19, 2026