Skip to content

unidix

by INTCO MEDICAL (HK) CO., ltd 4 variants

Ref EP015M

Active European Union

CE MDD

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 7 Nov 2026. What this means

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-14895272902441 Basic UDI-DI 14895272902441UDI-DIDate22 Oct 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Active

Specification

EUDAMED

Device Name
Electrosurgical pencil
Model / Reference
EP015M
Primary DI / UDI-DI
14895272902441
Basic UDI-DI
B-14895272902441
EMDN Code
K0201010201 Open electrosurgery dissectors, single-use
Device Class
Class IIb
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000011338
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from INTCO MEDICAL (HK) CO., ltd

See all devices from INTCO MEDICAL (HK) CO., ltd →

Properties

  • Sterile

Other properties (10)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No