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WEGO-PGCL Absorbable Surgical Suture With Needle Q63193

by Foosin Medical Supplies, Inc.

Ref A43163-75Model PGLA

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

CE MDD

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/MDD EUDAMED NumberB-06941813630845 Basic UDI-DI 06941813630845UDI-DIDate20 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06941813630845 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  • Withdrawn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/MDD 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
PGLA EUDAMED
A43163-75 EUDAMED
Q63193 GUDID
Primary DI / UDI-DI
06941813630845
Basic UDI-DI
B-06941813630845
510(k) Number
FDA Product Code
GAM
EMDN Code
H010101020201, H010101020202
GMDN Term
Polyester suture, bioabsorbable, multifilament, non-antimicrobial
Device Class
Class III EUDAMED
Class II GUDID
Regulation Number
878.4493
EU market of registration
Lithuania
GUDID distribution status
Not in Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
PGLA
A43163-75
GUDID
Q63193
Device ClassEUDAMED
Class III
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
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (15)

  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: 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