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BATIST Sterile Infusion sets for single use (Gravity feed) IS-G-A6

by Anhui Hongyu Wuzhou Medical Manufacturer CO., Ltd.

Ref 1321610901

Active European Union

CE MDR

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69586976HWSYQ0014K Basic UDI-DI 06958697609478UDI-DIDate12 Apr 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

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Infusion sets for single use (Gravity feed)
Model / Reference
1321610901
Primary DI / UDI-DI
06958697609478
Basic UDI-DI
69586976HWSYQ0014K
EMDN Code
A03040199 Infusion kits (with or w/o pump), single-use - other
Device Class
Class IIa
EU market of registration
Czechia

Manufacturer details

EUDAMED SRN
CN-MF-000029789
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

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Properties

  • Sterile
  • Administering Medicine

Other properties (11)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No