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Aesculap FK135R

by Aesculap AG

Part of a family of 37 devices: see the family page

Ref FK135R

Aesculap FK135R is a Class I device made by Aesculap AG, registered in EUDAMED on 16 Sep 2025 (Basic UDI-DI 40392390000003692J) and listed in FDA GUDID since 20 Apr 2020 (UDI-DI 04038653044924), 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 Number40392390000003692J Basic UDI-DI 04038653044924UDI-DIDate16 Sep 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number04038653044924 UDI-DI Date20 Apr 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 40392390000003692J registered 16 Sep 2025 Active
  • FDA GUDID UDI-DI 04038653044924 listed 20 Apr 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04038653044924
  2. Registered EUDAMED 40392390000003692J

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  • Withdrawn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
Open-surgery dissector
Model / Ref / Catalog
FK135R
Primary DI / UDI-DI
04038653044924
Basic UDI-DI
40392390000003692J
Direct marketing DI
04038653044924
FDA product code
GEG
EMDN code
L0902 Orthopaedic surgery levers, reusable
GMDN term
Open-surgery dissector
Device class
Class I
Regulation number
878.4800
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Open-surgery dissector

Similar devices in this category

Other devices filed under ORTHOPAEDIC SURGERY LEVERS, REUSABLE.

Other devices from Aesculap AG

See all devices from Aesculap AG →

Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (20, all answered No)