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Ostene 1503833

by Apatech Ltd

Ref 1503833

Ostene 1503833 is a device classified as Class III (EU), Unclassified (US) made by Apatech Ltd, registered in EUDAMED on 13 Jul 2026 (Basic UDI-DI B-05413760467474) and listed in FDA GUDID since 24 Sep 2015 (UDI-DI 05413760467474), active as of 23 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDD

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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-05413760467474 Basic UDI-DI 05413760467474UDI-DIDate13 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05413760467474 UDI-DI Date24 Sep 2015ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-05413760467474 registered 13 Jul 2026 Active
  • FDA GUDID UDI-DI 05413760467474 listed 24 Sep 2015 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 05413760467474
  2. Registered EUDAMED B-05413760467474

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Ostene
Generic name
Bone wax, synthetic
Device name
Ostene Bone Hemostasis Material
Model / Ref / Catalog
1503833
Primary DI / UDI-DI
05413760467474
Basic UDI-DI
B-05413760467474
FDA product code
MTJ
EMDN code
M040506 Hemostatic waxes
GMDN term
Bone wax, synthetic
Device class
Class III EUDAMED
U GUDID
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Size
Weight — 1 Gram

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class III
GUDID
U

Device class is stated on each registry's own scale: Class III in the EU (EUDAMED), U in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Bone wax, synthetic

Similar devices in this category

Other devices filed under HEMOSTATIC WAXES.

Other devices from Apatech Ltd

See all devices from Apatech Ltd →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (17, all answered No)