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Manche Bistouri

by New Deantronics Taiwan Ltd. 2 variants

Ref BE500Model PEN05, PEN51, EPEN51, PEN55, PEN06, PEN61, BE500, EPEN05, EPEN55, EPEN06, EPEN61

Active European Union

CE MDR

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number081352702FP012B110011RH Basic UDI-DI 03663996012708UDI-DIDate3 Mar 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  • Withdrawn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/MDR Active

Specification

EUDAMED

Device Name
Foot Control Pencil
Model / Reference
PEN05, PEN51, EPEN51, PEN55, PEN06, PEN61, BE500, EPEN05, EPEN55, EPEN06, EPEN61
Primary DI / UDI-DI
03663996012708
Basic UDI-DI
081352702FP012B110011RH
EMDN Code
K0201010501 Open electrosurgery handpieces, single-use
Device Class
Class IIb
EU market of registration
France

Manufacturer details

EUDAMED SRN
TW-MF-000013730
Authorised representative
mediworx.one GmbH DE-AR-000005583

Other devices from New Deantronics Taiwan Ltd.

Properties

  • Sterile

Other properties (12)

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