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PENTAX Medical Single Use Balloon OE-A61

by PENTAX Medical Corporation Japan EUDAMED

Ref 04580826926372Model See UDI-DI information for model names

EMDN G0380

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number458082692010518LL Basic UDI-DIDate5 Aug 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
PENTAX Medical Single Use Balloon
Model / Reference
See UDI-DI information for model names, 04580826926372
Primary DI / UDI-DI
04580826926372
Basic UDI-DI
458082692010518LL
Unit of Use DI
84580826926378
EMDN Code
G0380 Digestive endoscopy devices - accessories
Device Class
Class I
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
JP-MF-000005227
Authorised representative
PENTAX Europe GmbH DE-AR-000000006

Other devices from PENTAX Medical Corporation

See all devices from PENTAX Medical Corporation →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Contains Latex
Other properties (11)
  • Implantable: No
  • Reusable: 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

Sources (1)

  • EUDAMED 94f77738-fd0c-4c55-b35c-224cbb87daf6 61 fields · synced 24 Oct 2026