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Ennovate SZ396R

by Aesculap AG

Part of a family of 71 devices: see the family page

Ref SZ396R

Ennovate SZ396R is a Class I device made by Aesculap AG, registered in EUDAMED on 31 Jul 2026 (Basic UDI-DI 4039239000000350ZS) and listed in FDA GUDID since 10 Aug 2020 (UDI-DI 04046964720345), active (EUDAMED), not in commercial distribution (GUDID) as of 12 Nov 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 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number4039239000000350ZS Basic UDI-DI 04046964720345UDI-DIDate31 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04046964720345 UDI-DI Date10 Aug 2020ListedStatusListed GUDID: not in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 4039239000000350ZS registered 31 Jul 2026 Active
  • FDA GUDID UDI-DI 04046964720345 listed 10 Aug 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04046964720345
  2. Registered EUDAMED 4039239000000350ZS

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  • Withdrawn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
Ennovate® EUDAMED
Ennovate GUDID
Generic name
Orthopaedic prosthesis implantation positioning instrument, reusable
Device name
ENNOVATE implant. instrument Ir
Model / Ref / Catalog
SZ396R
Primary DI / UDI-DI
04046964720345
Basic UDI-DI
4039239000000350ZS
Direct marketing DI
04046964720345
FDA product code
LXH
EMDN code
L091099 Osteosynthesis instruments, reusable - other
GMDN term
Orthopaedic prosthesis implantation positioning instrument, reusable
Device class
Class I
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

Related devices

Category: Orthopaedic prosthesis implantation positioning instrument, reusable

Similar devices in this category

Other devices filed under OSTEOSYNTHESIS INSTRUMENTS, REUSABLE - OTHER.

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)