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Electrosurgical Unit

EUDAMED

Class IIb (EU MDR)

Ref DOCTANZ150

by Zerone Co., Ltd.

Identity

Trade Name
Electrosurgical Unit EUDAMED
Device Name
Electrosurgical Unit EUDAMED
Model / Reference
DOCTANZ150 EUDAMED

Identifiers

Primary DI / UDI-DI
08809417420089 EUDAMED
Basic UDI-DI
B-08809417420089 EUDAMED
EMDN Code
Z12010902 ELECTROSURGICAL UNITS (ESU) FOR GENERAL USE EUDAMED

Classification

Device Class
Class IIb EUDAMED
Market of Registration
Italy EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Implantable

No

EUDAMED

Reusable

Yes

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

Electrosurgical Unit by Zerone Co., Ltd. — Class IIb — 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
Zerone Co., Ltd.
EUDAMED SRN
KR-MF-000014148
Authorised Representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Sources (1)

  • EUDAMED 7317734a-16ac-4ddb-a2fd-5fab29af31d5 61 fields · synced Jun 18, 2026