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Olympus A60100A

by Olympus Winter & Ibe GmbH

Ref A60100A

Olympus A60100A 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 12 Oct 2026 (Basic UDI-DI B-04042761009720), cleared under FDA 510(k) K944200 on 15 Sep 1995 (1 earlier submission) and listed in FDA GUDID since 21 Sep 2016 (UDI-DI 04042761009720), active as of 24 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K944200

+1 more

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04042761009720 Basic UDI-DI 04042761009720UDI-DIDate12 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04042761009720 UDI-DI Date21 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK944200 Date15 Sep 1995DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-04042761009720 registered 12 Oct 2026 Active
  • FDA 510(k) K944200 decided 15 Sep 1995 Active· +1 more in the status table
  • FDA GUDID UDI-DI 04042761009720 listed 21 Sep 2016 Listed

Timeline

4 dated events

  1. Cleared FDA 510(k) K944201
  2. Cleared FDA 510(k) K944200
  3. Listed FDA GUDID 04042761009720
  4. Registered EUDAMED B-04042761009720

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Handle "HiQ+", Ergo, ratchet EUDAMED
Olympus GUDID
Generic name
Surgical instrument handle, non-torque-limiting
Model / Ref / Catalog
A60100A
Primary DI / UDI-DI
04042761009720
Basic UDI-DI
B-04042761009720
510(k) Number
FDA product code
GCJ, HET
EMDN code
L180302 Endoscopic electrosurgery handpieces, reusable
GMDN term
Surgical instrument handle, non-torque-limiting
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
876.1500, 884.1720
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

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: Surgical instrument handle, non-torque-limiting

Cleared under the same submission (K944200)

and 8 more cleared under K944200

Cleared under the same submission (K944201)

and 8 more cleared under K944201

Similar devices in this category

Other devices filed under ENDOSCOPIC ELECTROSURGERY HANDPIECES, REUSABLE.

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See all devices from Olympus Winter & Ibe GmbH →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
Other properties (22, all answered No)