Skip to content

Aesculap GC355R

by Aesculap AG

Ref GC355R

Aesculap GC355R is a device classified as Class IIa in the EU and Class I in the US made by Aesculap AG, registered in EUDAMED on 25 Nov 2025 (Basic UDI-DI 403923900000186336) and listed in FDA GUDID since 20 Apr 2020 (UDI-DI 04038653071920), 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 Number403923900000186336 Basic UDI-DI 04038653071920UDI-DIDate25 Nov 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number04038653071920 UDI-DI Date20 Apr 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 403923900000186336 registered 25 Nov 2025 Active
  • FDA GUDID UDI-DI 04038653071920 listed 20 Apr 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04038653071920
  2. Registered EUDAMED 403923900000186336

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  • Withdrawn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
Surgical screwdriver, reusable
Device name
Screwdriver
Model / Ref / Catalog
GC355R
Primary DI / UDI-DI
04038653071920
Basic UDI-DI
403923900000186336
FDA product code
HXX
EMDN code
Z12019080 Various instruments for general and multidisciplinary surgery - hardware accessories
GMDN term
Surgical screwdriver, reusable
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
888.4540
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 I

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class I 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 VARIOUS INSTRUMENTS FOR GENERAL AND MULTIDISCIPLINARY SURGERY - HARDWARE ACCESSORIES.

Other devices from Aesculap AG

See all devices from Aesculap AG →

Properties

  • Sterilise before use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (21, all answered No)