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Mani Sutures Silk - 4-0 Silk

by Mani, Inc. EUDAMED

Active European Union

Ref 1

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number4546951000004ZF Basic UDI-DIDate18 Jun 2026RegisteredStatusActive

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  • Withdrawn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

Device Name
Mani Sutures Silk
Model / Reference
1
Primary DI / UDI-DI
04546951633226
Basic UDI-DI
4546951000004ZF
EMDN Code
H010202020301 Silk with needle
Device Class
Class IIb
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
JP-MF-000017860
Authorised representative
Obelis s.a. BE-AR-000000106

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Properties

Show properties
  • Sterile
  • Implantable
  • Sutures
  • CMR Substance
Other properties (10)
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No