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Sayan

by Sayan Tıbbi Aletler Paz. San. ve Tic. Ltd. Şti. 3 variants

Ref 1100.12.038

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

CE MDD

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number08698940967426 UDI-DI Date3 Jun 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDD EUDAMED NumberB-08698940967426 Basic UDI-DI 08698940967426UDI-DIDate12 May 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

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  • Withdrawn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

Generic Name
Orthopaedic prosthesis implantation positioning instrument, reusable
Model / Ref / Catalog
1100.12.038
Primary DI / UDI-DI
08698940967426
Basic UDI-DI
B-08698940967426
FDA Product Code
LXH
EMDN Code
L0999 Orthopaedic and traumatological surgery instruments, reusable - other
GMDN Term
Orthopaedic prosthesis implantation positioning instrument, reusable
Device Class
Class I
Regulation Number
888.4540
EU market of registration
Austria
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Manufacturer details

EUDAMED SRN
TR-MF-000015714

Other devices from Sayan Tıbbi Aletler Paz. San. ve Tic. Ltd. Şti.

See all devices from Sayan Tıbbi Aletler Paz. San. ve Tic. Ltd. Şti. →

Properties

  • Reusable
  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (18)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No