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Electric Implant Torque Wrench

EUDAMED

Class I (EU MDR)

Ref D-P.15.16-D01Model E-MATE SURGIC-W

by Shenzhen Denco Medical Co., Ltd.

Identity

Device Name
Electric Implant Torque Wrench EUDAMED
Model / Reference
E-MATE SURGIC-W EUDAMED
D-P.15.16-D01 EUDAMED

Identifiers

Primary DI / UDI-DI
06975718059289 EUDAMED
Basic UDI-DI
69757180592TWL2 EUDAMED
EMDN Code
Z12110199 INSTRUMENTS FOR DENTAL TREATMENT UNITS - OTHER EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Türkiye EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Electric Implant Torque Wrench by Shenzhen Denco Medical Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

EUDAMED SRN
CN-MF-000014271
Authorised Representative
Share info GmbH DE-AR-000005132

Sources (1)

  • EUDAMED b2ac8c57-9efd-4382-9c73-20936abce76a 61 fields · synced Jul 9, 2026