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Olympus GWH3505R

by Gyrus Acmi, Inc.

Ref GWH3505R

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

CE MDD

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/MDD EUDAMED NumberB-00821925031180 Basic UDI-DI 00821925031180UDI-DIDate28 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00821925031180 UDI-DI Date13 Sep 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  • Withdrawn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/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Olympus
Generic Name
Gastro-urological guidewire, single-use
Device Name
GWH3505R
Model / Reference
GWH3505R
Primary DI / UDI-DI
00821925031180 EUDAMED
00821925031425 GUDID
Basic UDI-DI
B-00821925031180
FDA Product Code
EYA
EMDN Code
U0601 Urological guidewires, hydrophilic
GMDN Term
Gastro-urological guidewire, single-use
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
876.5130
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
00821925031180
GUDID
00821925031425
Device ClassEUDAMED
Class IIa
GUDID
Class I

Related devices

Category: Gastro-urological guidewire, single-use

Other devices from Gyrus Acmi, Inc.

See all devices from Gyrus Acmi, Inc. →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration 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
  • Serial Number: No
  • Manufacturing Date: No