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Sayan

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

Ref 1060.51.033

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number08698940972147 UDI-DI Date3 Mar 2023ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDD EUDAMED NumberB-08698940972147 Basic UDI-DI 08698940972147UDI-DIDate30 Jan 2023RegisteredStatusActive

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  • Withdrawn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
1060.51.033
Primary DI / UDI-DI
08698940972147
Basic UDI-DI
B-08698940972147
FDA Product Code
LXH
EMDN Code
L091199 Orthopaedic prosthetics instruments, reusable - other
GMDN Term
Orthopaedic prosthesis implantation positioning instrument, reusable
Device Class
Class I
Regulation Number
888.4540
EU market of registration
Belgium
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

Other properties (19)

  • 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
  • Manufacturing Date: No