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Absorbable Surgical Suture With / Without Needle - PGLA Suture

by Huaiyin Medical Instruments Co., Ltd 17 variants

Ref PGLA70140B0Model With Needle

Active European Union

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-06938535513822 Basic UDI-DI 06938535513822UDI-DIDate23 Jun 2026RegisteredStatusActive

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.

Coverage

1 jurisdiction

DenmarkNetherlandsGermanyPolandRomaniaTürkiye
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDD Active

EU market availability

Made available in 6 countries, as listed in EUDAMED:

Declared by the manufacturer in EUDAMED for this device version; may not cover every market.

  • Denmark since 1 Mar 2024
  • Germany since 1 Jan 2023
  • Netherlands since 1 Jan 2023
  • Poland since 1 Jan 2023
  • Romania since 1 Jan 2023
  • Türkiye since 1 Jan 2024

Last checked 2 Nov 2026.

Specification

EUDAMED

Device Name
Absorbable Surgical Suture With / Without Needle - PGLA Suture
Model / Reference
With Needle, PGLA70140B0
Primary DI / UDI-DI
06938535513822
Basic UDI-DI
B-06938535513822
EMDN Code
H010101020201 Polyglycolic with lactic acid multifilament with needle for open surgery
Device Class
Class III
EU market of registration
Denmark

Manufacturer details

EUDAMED SRN
CN-MF-000003351
Authorised representative
Wellkang Ltd XI-AR-000001836

Other devices from Huaiyin Medical Instruments Co., Ltd.

See all devices from Huaiyin Medical Instruments Co., Ltd. →

Properties

  • Sterile
  • Implantable

Other properties (9)

  • 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