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HighSOAK

by Madhu Instruments Private Limited EUDAMED

Active European Union

Ref MIPL/B1/5Model Cellulose Sponge Spear

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08906025961772 Basic UDI-DIDate29 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDD Expiring

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Specification

EUDAMED

Device Name
Fluid Management Device
Model / Reference
Cellulose Sponge Spear, MIPL/B1/5
Primary DI / UDI-DI
08906025961772
Basic UDI-DI
B-08906025961772
EMDN Code
Q021199 Ophthalmic surgery instruments, single-use - other
Device Class
Class I
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IN-MF-000017447
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from Madhu Instruments Private Limited

See all devices from Madhu Instruments Private Limited →

Properties

  • Sterile

Other properties (10)

  • Implantable: No
  • 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