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WEGO-PGCL Absorbable Surgical Suture With Needle Q43192

by Foosin Medical Supplies, Inc.

Ref Z43183-45Model PTFE

Active European Union. Also listed in GUDID (US), not in commercial distribution.

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number69418136NA-suturesIIbZ8H Basic UDI-DI 06941813630654UDI-DIDate11 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06941813630654 UDI-DI Date18 Apr 2016ListedStatusListed GUDID: not in commercial distribution

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 found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade Name
WEGO-PGCL Absorbable Surgical Suture With Needle
Generic Name
Polyester suture, bioabsorbable, multifilament, non-antimicrobial
Model / Reference
PTFE EUDAMED
Z43183-45 EUDAMED
Q43192 GUDID
Primary DI / UDI-DI
06941813630654
Basic UDI-DI
69418136NA-suturesIIbZ8H
Direct Marketing DI
06941813630654
510(k) Number
FDA Product Code
GAM
EMDN Code
H010201010501, H010201010502
GMDN Term
Polyester suture, bioabsorbable, multifilament, non-antimicrobial
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
878.4493
EU market of registration
Romania
GUDID distribution status
Not in Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
PTFE
Z43183-45
GUDID
Q43192
Device ClassEUDAMED
Class IIb
GUDID
Class II

Related devices

Cleared under the same submission (K142810)

Other devices from Foosin Medical Supplies, Inc.

See all devices from Foosin Medical Supplies, Inc. →

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