Skip to content

Aesculap GB896R

by Aesculap AG

Part of a family of 31 devices: see the family page

Ref GB896R

Aesculap GB896R is a device classified as Class IIa in the EU and Class II in the US made by Aesculap AG, registered in EUDAMED on 18 Nov 2025 (Basic UDI-DI 403923900000052426) and listed in FDA GUDID since 18 Mar 2022 (UDI-DI 04046964810428), active as of 12 Nov 2026.

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

CE MDR

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 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number403923900000052426 Basic UDI-DI 04046964810428UDI-DIDate18 Nov 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number04046964810428 UDI-DI Date18 Mar 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 403923900000052426 registered 18 Nov 2025 Active
  • FDA GUDID UDI-DI 04046964810428 listed 18 Mar 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04046964810428
  2. Registered EUDAMED 403923900000052426

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  • Withdrawn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
Aesculap
Generic name
Bone/joint surgical power tool motorized handpiece/set, electric, reusable
Device name
ACCULAN attachment
Model / Ref / Catalog
GB896R
Primary DI / UDI-DI
04046964810428
Basic UDI-DI
403923900000052426
Direct marketing DI
04046964810428
FDA product code
HBE
EMDN code
Z12130580 Motorised orthopaedic surgery system instruments - hardware accessories
GMDN term
Bone/joint surgical power tool motorized handpiece/set, electric, reusable
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
882.4310
EU registration type
Standard device
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 IIa
GUDID
Class II

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

Similar devices in this category

Other devices filed under MOTORISED ORTHOPAEDIC SURGERY SYSTEM INSTRUMENTS - HARDWARE ACCESSORIES.

Other devices from Aesculap AG

See all devices from Aesculap AG →

Properties

  • Sterilise before use
  • Prescription use
  • Serial number
Other properties (22, all answered No)