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PENTAX Medical Single Use Suction Control Valve OF-B205

by PENTAX Medical Corporation 2 variants

Ref 6217001A027SModel OF-B205

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
European UnionCE/MDR EUDAMED Number4961333010513Y7 Basic UDI-DI 14961333221438UDI-DIDate18 Feb 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number14961333221438 UDI-DI Date19 Dec 2018ListedStatusListed GUDID: in commercial distribution

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  • Withdrawn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 Single Use Suction Control Valve OF-B205 EUDAMED
PENTAX Medical GUDID
Generic Name
Endoscope suction valve, single-use
Model / Reference
OF-B205, 6217001A027S
Primary DI / UDI-DI
14961333221438
Basic UDI-DI
4961333010513Y7
Unit of Use DI
04961333221431
FDA Product Code
EOB
EMDN Code
G0380 Digestive endoscopy devices - accessories
GMDN Term
Endoscope suction valve, single-use
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
874.4760
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

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

Related devices

Category: Gastro-urological guidewire, single-use

Other devices from PENTAX Medical Corporation

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Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (18)

  • 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