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Abc E-Plate

by Aesculap AG 3 variants

Part of a family of 13 devices: see the family page

Ref FJ837R

Abc E-Plate (FJ837R) is a device classified as Class IIa in the EU and Class I in the US made by Aesculap AG, registered in EUDAMED on 18 Nov 2025 (Basic UDI-DI 40392390000005442C) and listed in FDA GUDID since 23 Apr 2020 (UDI-DI 04038653304899), active (EUDAMED), not in commercial distribution (GUDID) as of 22 Oct 2026.

Active European Union. Also listed in GUDID (US), not in commercial distribution.

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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number40392390000005442C Basic UDI-DI 04038653304899UDI-DIDate18 Nov 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number04038653304899 UDI-DI Date23 Apr 2020ListedStatusListed GUDID: not in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 40392390000005442C registered 18 Nov 2025 Active
  • FDA GUDID UDI-DI 04038653304899 listed 23 Apr 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04038653304899
  2. Registered EUDAMED 40392390000005442C

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  • Withdrawn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

Generic name
Orthopaedic prosthesis implantation positioning instrument, reusable
Device name
ABC implantation instrument IIa RU
Model / Ref / Catalog
FJ837R
Primary DI / UDI-DI
04038653304899
Basic UDI-DI
40392390000005442C
FDA product code
HXX
EMDN code
L091199 Orthopaedic prosthetics instruments, reusable - other
GMDN term
Orthopaedic prosthesis implantation positioning instrument, 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
Not 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.

Manufacturer details

EUDAMED SRN
DE-MF-000005504

Similar devices in this category

Other devices filed under ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER.

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)