Skip to content

exofin Fusion Skin Closure System 22cm

by Chemence Medical Inc. United States EUDAMED

Ref EF70430CEModel EF70422CE EMDN H900199

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number854137001OMDJZ Basic UDI-DIDate17 Mar 2023RegisteredStatusActive

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  • Withdrawn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

Device Name
exofin Fusion Skin Closure System 22cm
Model / Reference
EF70422CE, EF70430CE
Primary DI / UDI-DI
00854137001412
Basic UDI-DI
854137001OMDJZ
Direct Marketing DI
00854137001412
EMDN Code
H900199 Tissue adhesives - other
Device Class
Class IIa
Market of Registration
Poland

Manufacturer details

EUDAMED SRN
US-MF-000000888
Authorised representative
Atlantico Systems, Ltd. IE-AR-000000208

Other devices from Chemence Medical Inc.

See all devices from Chemence Medical 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 431c5811-f910-4ddd-9ee6-5344bd84d6c2 61 fields · synced 24 Oct 2026