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PENTAX Medical Cleaning Adapter OF-B212

by PENTAX Medical Corporation

Ref 6217001A028SModel See UDI-DI information for model names

Withdrawn Withdrawn in European Union. No longer placed on the EU market.

Was authorized under CE MDR, withdrawn

Ended

Withdrawn

Date not published (CE MDR)

FDA recalls

None found

in data synced 24 Oct 2026

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 Number04961333221448 UDI-DI Date31 Jul 2023ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number4961333010509YG Basic UDI-DI 04961333221448UDI-DIDate12 Jul 2022RegisteredStatusWithdrawn No longer placed on the EU market

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.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 24 Oct 2026.

Coverage

2 jurisdictions

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  • Withdrawn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  • European Union CE/MDR Withdrawn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

Specification

EUDAMED · GUDID

Trade Name
PENTAX Medical Cleaning Adapter OF-B212 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
6217001A028S EUDAMED
OF-B212 GUDID
Primary DI / UDI-DI
04961333221448
Basic UDI-DI
4961333010509YG
FDA Product Code
EOB, PEA
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
874.4760, 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
6217001A028S
GUDID
OF-B212
Device ClassEUDAMED
Class I
GUDID
Class II

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

  • Reusable
  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (20)

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