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Aesculap JA415R

by Aesculap AG

Part of a family of 8 devices: see the family page

Ref JA415R

Aesculap JA415R is a Class I device made by Aesculap AG, registered in EUDAMED on 25 Sep 2025 (Basic UDI-DI 4039239000000420ZN) and listed in FDA GUDID since 10 Aug 2020 (UDI-DI 04046964140778), 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 Number4039239000000420ZN Basic UDI-DI 04046964140778UDI-DIDate25 Sep 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number04046964140778 UDI-DI Date10 Aug 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 4039239000000420ZN registered 25 Sep 2025 Active
  • FDA GUDID UDI-DI 04046964140778 listed 10 Aug 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04046964140778
  2. Registered EUDAMED 4039239000000420ZN

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  • Withdrawn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 instrument/implant rack
Device name
UNIVATION instrument tray
Model / Ref / Catalog
JA415R
Primary DI / UDI-DI
04046964140778
Basic UDI-DI
4039239000000420ZN
Direct marketing DI
04046964140778
FDA product code
FSM
EMDN code
S010401 Trays, baskets, tubs for sterilisation and their components
GMDN term
Surgical instrument/implant rack
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: Surgical instrument/implant rack

Similar devices in this category

Other devices filed under TRAYS, BASKETS, TUBS FOR STERILISATION AND THEIR COMPONENTS.

Other devices from Aesculap AG

See all devices from Aesculap AG →

Properties

  • Sterilise before use
  • Over-the-counter
  • Premarket exempt
  • Lot / batch number
Other properties (21, all answered No)