Skip to content

Olympus A44728C

by Olympus Winter & Ibe GmbH

Ref A44728C

Olympus A44728C is a device classified as Class IIb in the EU and Class II in the US made by Olympus Winter & Ibe GmbH, registered in EUDAMED on 26 Oct 2026 (Basic UDI-DI B-14042761039090) and listed in FDA GUDID since 21 Sep 2016 (UDI-DI 14042761039090), active as of 7 Nov 2026.

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

CE MDD

Valid until

No date given

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

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-14042761039090 Basic UDI-DI 14042761039090UDI-DIDate26 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number14042761039090 UDI-DI Date21 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-14042761039090 registered 26 Oct 2026 Active
  • FDA GUDID UDI-DI 14042761039090 listed 21 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 14042761039090
  2. Registered EUDAMED B-14042761039090

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  • Withdrawn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
HF-resection electrode, cylinder, with spikes, 24-28 Fr., 12° und 30°, sterile, single use, 12 pcs. EUDAMED
Olympus GUDID
Generic name
Endoscopic electrosurgical electrode, monopolar, single-use
Model / Ref / Catalog
A44728C
Primary DI / UDI-DI
14042761039090
Basic UDI-DI
B-14042761039090
FDA product code
HIH, FJL, FAS
EMDN code
K02030101 Radiofrequency surgery electrodes, single-use
GMDN term
Endoscopic electrosurgical electrode, monopolar, single-use
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
884.1690, 876.1500, 876.4300
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilisation method
Ethylene Oxide

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II
Sterilise before useEUDAMED
No
GUDID
Yes

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Sterilise before use UDI-DI 14042761039090: EUDAMED states No, FDA GUDID states Yes.

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Endoscopic electrosurgical electrode, monopolar, single-use

Similar devices in this category

Other devices filed under RADIOFREQUENCY SURGERY ELECTRODES, SINGLE-USE.

Other devices from Olympus Winter & Ibe GmbH

  • Oes Elite WA2C2ASB

    Class II

  • Oes Elite WA2C21LO

    Class II

  • Oes Elite WA2C17BS

    Class II

  • Oes Elite WA2C21BS

    Class II

See all devices from Olympus Winter & Ibe GmbH →

Properties

  • Supplied sterile
  • Sterilise before use NoEUDAMEDYesGUDID
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)