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ENER REACH Enerseal

by Reach Surgical, Inc. China EUDAMED

Ref OSA44Model OSA23,OSA37,OSA44 EMDN K0201010502

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69538158Y104TW Basic UDI-DIDate11 Sep 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
OSA23, OSA37, OSA44
Primary DI / UDI-DI
06953815803196
Basic UDI-DI
69538158Y104TW
EMDN Code
K0201010502 Laparoscopic and thoracoscopic electrosurgery handpieces, single-use
Device Class
Class IIb
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000011148
Authorised representative
MDSS GmbH DE-AR-000005430

Other devices from Reach Surgical, Inc.

See all devices from Reach Surgical, Inc. →

Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED bf36dccf-04b7-4034-83f4-fbabd34791d2 61 fields · synced 24 Oct 2026