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Ostene 1503831

by Apatech Ltd

Ref 1503831

Ostene 1503831 is a device classified as Class III (EU), Unclassified (US) made by Apatech Ltd, registered in EUDAMED on 13 Feb 2026 (Basic UDI-DI 506005078000000000026QP) and listed in FDA GUDID since 24 Sep 2015 (UDI-DI 05413760467450), active as of 7 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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number506005078000000000026QP Basic UDI-DI 05413760467450UDI-DIDate13 Feb 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05413760467450 UDI-DI Date24 Sep 2015ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 506005078000000000026QP registered 13 Feb 2026 Active
  • FDA GUDID UDI-DI 05413760467450 listed 24 Sep 2015 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 05413760467450
  2. Registered EUDAMED 506005078000000000026QP

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  • Withdrawn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
Ostene
Generic name
Bone wax, synthetic
Model / Ref / Catalog
1503831
Primary DI / UDI-DI
05413760467450
Basic UDI-DI
506005078000000000026QP
FDA product code
MTJ
EMDN code
M040506 Hemostatic waxes
GMDN term
Bone wax, synthetic
Device class
Class III EUDAMED
U GUDID
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Size
Weight — 3.5 Gram

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class III
GUDID
U
ImplantableEUDAMED
No
GUDID
Yes

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 NoEUDAMEDYesGUDID
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)