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Sterile and Non-sterile reusable high frequency electrosurgical pencils, with or without electrode, for monopolar cutting and coagulation during open electrosurgery

by Modern Medical Equipment Manufacturing Ltd. United States EUDAMED

Ref PR617-FG19550Model PR

EMDN L180301

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69390298REP7E Basic UDI-DIDate25 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
PR, PR617-FG19550
Primary DI / UDI-DI
06939029818546
Basic UDI-DI
69390298REP7E
Direct Marketing DI
06939029818546
EMDN Code
L180301 Open electrosurgery handpieces, reusable
Device Class
Class IIb
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
HK-MF-000001781
Authorised representative
Emergo Europe B.V. NL-AR-000000116

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Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Reusable
Other properties (11)
  • Implantable: 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

Sources (1)

  • EUDAMED f6bf7d7b-26f1-4e25-bb6f-ae48bd76159b 61 fields · synced 22 Oct 2026