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PENTAX Medical OE-B10

by Pentax Medical Company

Ref 04580826926518Model See UDI-DI information for model names

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number04580826926518 UDI-DI Date25 Aug 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number458082692010509LK Basic UDI-DI 04580826926518UDI-DIDate5 Aug 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

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
PENTAX Medical Cleaning Adapter OE-B10 EUDAMED
PENTAX Medical GUDID
Generic Name
Endoscope flushing adaptor, reusable
Device Name
Channel Cleaning Adapter
Model / Reference
See UDI-DI information for model names EUDAMED
04580826926518 EUDAMED
OE-B10 GUDID
Primary DI / UDI-DI
04580826926518
Basic UDI-DI
458082692010509LK
Direct Marketing DI
04580826926518
FDA Product Code
ITX, ODG
EMDN Code
V0799 Products for cleaning medical devices not included in other classes - other
GMDN Term
Endoscope flushing adaptor, reusable
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
892.1570, 876.1500
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
See UDI-DI information for model names
04580826926518
GUDID
OE-B10
Device ClassEUDAMED
Class I
GUDID
Class II

Other devices from Pentax Medical Company

See all devices from Pentax Medical Company →

Properties

  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (21)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No