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Bimanual I/A System reusable (T)

by Bürki inno med AG EUDAMED

Active European Union

Ref 1901-5623

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number764013745P02P04X4 Basic UDI-DIDate24 Apr 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates

0 certificates · EUDAMED

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

Specification

EUDAMED

Device Name
I/A System reusable
Model / Reference
1901-5623
Primary DI / UDI-DI
07640137454081
Basic UDI-DI
764013745P02P04X4
Direct Marketing DI
07640137454081
EMDN Code
Q0299 Ophthalmic devices - other
Device Class
Class I
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CH-MF-000017443
Authorised representative
Bürki inno med GmbH DE-AR-000008073

From the manufacturer

Manufacturer's product page: Bimanual I/A System reusable 20G, 21G, 22G, 23G

Other devices from Bürki inno med AG

See all devices from Bürki inno med AG →

Properties

  • Reusable

Other properties (12)

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