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WEGO-SILK Non-absorbable Surgical Suture With Needle S2007510

by Foosin Medical Supplies, Inc. EUDAMEDGUDID

Active European Union

Ref S2007510Model Silk

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number69418136NN-suturesIIbSQQ Basic UDI-DIDate3 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06942339395614 UDI-DIDate28 Sep 2015ListedStatusListed GUDID: not in commercial distribution

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

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.

Recalls

0 recalls · FDA

No FDA recalls on record, checked 23 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
WEGO-SILK Non-absorbable Surgical Suture With Needle
Generic Name
Silk suture
Model / Reference
S2007510, Silk
Primary DI / UDI-DI
06942339395614 EUDAMED
06941813650638 GUDID
Basic UDI-DI
69418136NN-suturesIIbSQQ
Direct Marketing DI
06942339395614
510(k) Number
FDA Product Code
GAP
EMDN Code
H010202020302 Silk without needle
GMDN Term
Silk suture
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
878.5030
Market of Registration
Greece
GUDID distribution status
Not in Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
06942339395614
GUDID
06941813650638
Device ClassEUDAMED
Class IIb
GUDID
Class II

Related devices

Cleared under the same submission (K080684)

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Properties

  • Sterile
  • Single Use
  • Implantable
  • Sutures
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (17)

  • 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No