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Flow Regulator / IV Flow Regulator / Flow Regulator Extension Set

by Harsoria Healthcare Pvt. Ltd.

Ref 6547Model Flow Regulator / IV Flow Regulator / Flow Regulator Extension Set

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number89043991HSETP0345 Basic UDI-DI 08908000465473UDI-DIDate4 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  • Withdrawn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

Model / Reference
Flow Regulator / IV Flow Regulator / Flow Regulator Extension Set, 6547
Primary DI / UDI-DI
08908000465473
Basic UDI-DI
89043991HSETP0345
EMDN Code
A030104 Flow regulators
Device Class
Class IIa
EU market of registration
Poland

Manufacturer details

EUDAMED SRN
IN-MF-000018349
Authorised representative
mdi Europa GmbH DE-AR-000006218

Other devices from Harsoria Healthcare Pvt. Ltd.

See all devices from Harsoria Healthcare Pvt. Ltd. →

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