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Aesculap FK635R

by Aesculap, Inc.

Part of a family of 173 devices: see the family page

Ref FK635R

Aesculap FK635R is a Class I device made by Aesculap, Inc., registered in EUDAMED on 15 Sep 2025 (Basic UDI-DI 403923900000040823) and listed in FDA GUDID since 10 Aug 2020 (UDI-DI 04038653045679), active as of 24 Oct 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number403923900000040823 Basic UDI-DI 04038653045679UDI-DIDate15 Sep 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number04038653045679 UDI-DI Date10 Aug 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 403923900000040823 registered 15 Sep 2025 Active
  • FDA GUDID UDI-DI 04038653045679 listed 10 Aug 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04038653045679
  2. Registered EUDAMED 403923900000040823

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  • Withdrawn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 curette, reusable
Device name
Spoon
Model / Ref / Catalog
FK635R
Primary DI / UDI-DI
04038653045679
Basic UDI-DI
403923900000040823
Direct marketing DI
04038653045679
FDA product code
FZS
EMDN code
L0901 Orthopaedic surgery spoons and curettes, reusable
GMDN term
Bone curette, reusable
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: Bone curette, reusable

Similar devices in this category

Other devices filed under ORTHOPAEDIC SURGERY SPOONS AND CURETTES, REUSABLE.

Other devices from Aesculap, Inc.

See all devices from Aesculap, Inc. →

Properties

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