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Sayan 1040.77.003

by Sayan Tibbi Aletler Pazarlama Sanayi Ve Ticaret Limited Sirketi

Ref 1040.77.003

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08698940936118 Basic UDI-DI 08698940936118UDI-DIDate21 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08698940936118 UDI-DI Date24 Dec 2024ListedStatusListed GUDID: in commercial distribution

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  • Withdrawn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

Trade Name
Sayan
Generic Name
Orthopaedic prosthesis implantation positioning instrument, reusable
Device Name
Acetabular Reamer Dome with Hex Coupling Ø44 mm
Model / Ref / Catalog
1040.77.003
Primary DI / UDI-DI
08698940936118
Basic UDI-DI
B-08698940936118
FDA Product Code
LXH
EMDN Code
L090999 Orthopaedic surgery cutting instruments, reusable - other
GMDN Term
Orthopaedic prosthesis implantation positioning instrument, reusable
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
888.4540
EU market of registration
Türkiye
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class I

Related devices

Category: Orthopaedic prosthesis implantation positioning instrument, reusable

Other devices from Sayan Tibbi Aletler Pazarlama Sanayi Ve Ticaret Limited Sirketi

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Properties

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

Other properties (17)

  • 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No