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Aesculap FC520R

by Aesculap AG

Ref FC520R

Aesculap FC520R is a Class I device made by Aesculap AG, registered in EUDAMED on 7 Jul 2025 (Basic UDI-DI 403923900000037125) and listed in FDA GUDID since 17 Jun 2020 (UDI-DI 04046964133886), 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 Number403923900000037125 Basic UDI-DI 04046964133886UDI-DIDate7 Jul 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number04046964133886 UDI-DI Date17 Jun 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 403923900000037125 registered 7 Jul 2025 Active
  • FDA GUDID UDI-DI 04046964133886 listed 17 Jun 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04046964133886
  2. Registered EUDAMED 403923900000037125

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  • Withdrawn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
Self-retaining surgical retractor, reusable
Device name
MIDCAB retractor set I
Model / Ref / Catalog
FC520R
Primary DI / UDI-DI
04046964133886
Basic UDI-DI
403923900000037125
Direct marketing DI
04046964133886
FDA product code
GAD
EMDN code
L07070202 Cardiac retractors, reusable
GMDN term
Self-retaining surgical retractor, 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

Similar devices in this category

Other devices filed under CARDIAC DILATORS AND RETRACTORS, REUSABLE.

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)