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Electrosurgical Unit

by Zerone Co., Ltd. 13 variants

Ref ZEUS PRIME, ACE-200, ZEUS-100, DOCTANZ300, ZEUS-300, ACE-150, DOCTANZ200S, ZEUS-150, DOCTANZ100, ACE-300, ACE-100, SENS-Z, DOCTANZ TOUCH

Electrosurgical Unit (ZEUS PRIME) is a medical device (EU MDD Class IIb; EMDN category electrosurgical units (esu) for general use) made by Zerone Co., Ltd., registered in EUDAMED on 4 May 2026 (Basic UDI-DI B-08809417420317), active as of 22 Oct 2026.

Active European Union

CE MDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08809417420317 Basic UDI-DI Date4 May 2026RegisteredStatusActive

Official records

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDD Active

Specification

EUDAMED

Model / reference
ZEUS PRIME, ACE-200, ZEUS-100, DOCTANZ300, ZEUS-300, ACE-150, DOCTANZ200S, ZEUS-150, DOCTANZ100, ACE-300, ACE-100, SENS-Z, DOCTANZ TOUCH
Primary DI / UDI-DI
08809417420317, 08809417420065, 08809417420287, 08809417420263, 08809417420256, 08809417420096, 08809417420140, 08809417420072, 08809417420294, 08809417420270, 08809417420300, 08809417420232, 08809417420171
Basic UDI-DI
B-08809417420317, B-08809417420065, B-08809417420287, B-08809417420263, B-08809417420256, B-08809417420096, B-08809417420140, B-08809417420072, B-08809417420294, B-08809417420270, B-08809417420300, B-08809417420232, B-08809417420171
EMDN code
Z12010902 Electrosurgical units (esu) for general use
Device class
Class IIb
EU registration type
Legacy device (under a directive)
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
KR-MF-000014148
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Related devices

Category: Foot-switch, electrical

Similar devices in this category

Other devices filed under ELECTROSURGICAL UNITS (ESU) FOR GENERAL USE.

Other devices from Zerone Co., Ltd.

See all devices from Zerone Co., Ltd. →

Properties

  • Reusable
Other properties (11, all answered No)