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Sayan

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

Ref 1100.31.065, 1040.40.054, 1020.01.091, 1041.81.003, 1041.73.003, 1042.13.003, 1040.61.054, 1070.30.035, 1040.80.054, 1080.01.034, 1081.00.027, 1100.20.038, 1070.01.016, 1070.90.028, 1070.12.035, 1070.57.001, 1020.20.162, 1070.58.001, 1030.20.005, 1100.40.038, 1070.54.001, 1100.20.060, 1100.81.038, 1020.04.072, 1100.30.038, 1040.22.039, 1040.00.011, 1100.51.038, 1070.55.001, 1100.40.060, 1080.40.027, 1040.10.011, 1072.54.001, 1070.09.033, 1100.70.038, 1050.00.008, 1050.00.002, 1070.59.001, 1072.52.001, 1070.51.001, 1070.03.032, 1030.01.005, 1070.53.001, 1100.18.023, 1071.53.001, 1060.01.008, 1100.30.060

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
European UnionCE/MDD EUDAMED NumberB-08698940974998 Basic UDI-DI Date18 Mar 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08698940974998 UDI-DI Date24 Jun 2022ListedStatusListed 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  • Withdrawn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 EUDAMEDGUDID
Threaded Guide Wire Trocar Ø3.2mm x 15mm x 200mm GUDID
Generic Name
Orthopaedic prosthesis implantation positioning instrument, reusable
Device Name
Handy I Ratchet Wrench In-Line AO X-Small Blue
Ø3.2 Mm Twist Drill with Pin 35mm X 25mm
Screwdriver with Handle 3,5 mm Screw Black
Acetabular Reamer with Carnet Arm Ø55 Mm
Mis Acetabular Reamer with Carnet Arm 54mm
Mis Acetabular Reamer with Carnet Arm 58mm
Ø3.2 Mm Twist Drill with Pin 45mm X 35mm
I Type Sequential Reducer
Ø3.2mm Twist Drill With Pin 55mm X 35mm
Femoral Stem Extractor Lever Type
ACETABULAR CUP MODULAR CUTTING BLADE 62mm
Hammer 300 gr
Ball Tip Control Probe with Ss Handle
Axial Persuader I Type Slim with Quick Coupling Grey
Tap 4,5 Size 1/4" Coupling Cannulated
Cannulated Small I Ratchet Handle Ao Coupling Green
Tap 5,5 Size 1/4" Coupling Cannulated
T HANDLE WITH ZIMMER COUPLING BLUE HANDLE L: 155mm
Hammer 450 gr
Narrow Probe Straight with Propylux Handle
Mjölnir Hammer 1250 gr
Depth Gauge 20mm
Hammer 400 gr
Handy Quick Coupling Screwdriver Bit SW3.5
Universal Screwdriver with Hudson Coupling HEX3,5MM
Mjölnir Hammer 500 gr
Curette with Propylux Handle
Handy Torque Limiting T Handle 12NM 1/4" Magenta
ACETABULAR CUP MODULAR CUTTING BLADE 50mm
Self Retaining Pendulum Joint Screwdriver HEX3.5MM 1/4" Coupling
Parallel Compressor Handle for Modular Tip
Handy Caspar Distractor Pin for Double Mobility Ss 16 Mm
Hammer 1000 gr
Grip Introducer
Cable Tensioner
Tap 6,5 Size 1/4" Coupling Cannulated
T-Handle Torquemeter 9NM 1/4" Coupling with Propylux Handle
Narrow Awl with Stop with Propylux Handle
Caspar Distractor with Double Mobility
T Handle with Ao Coupling Blue Handle Short
Narrow Probe Curved with Propylux Handle
Adaptor Jacobs Male - Ao Female
Freehand Polyaxial Screwdriver T20 with 1/4" Coupling
Em Tibial Alignment Guide
Torque Limiting Small T Handle 2,3NM 1/4" Blue
Model / Ref / Catalog
1100.31.065, 1040.40.054, 1020.01.091, 1041.81.003, 1041.73.003, 1042.13.003, 1040.61.054, 1070.30.035, 1040.80.054, 1080.01.034, 1070.90.028, 1100.20.060, 1081.00.027, 1100.20.038, 1070.01.016, 1070.12.035, 1070.57.001, 1020.20.162, 1070.58.001, 1030.20.005, 1100.40.038, 1070.54.001, 1100.81.038, 1020.04.072, 1100.30.038, 1040.22.039, 1040.00.011, 1100.51.038, 1070.55.001, 1100.40.060, 1080.40.027, 1040.10.011, 1072.54.001, 1070.09.033, 1100.70.038, 1050.00.008, 1050.00.002, 1070.59.001, 1072.52.001, 1070.51.001, 1070.03.032, 1030.01.005, 1070.53.001, 1100.18.023, 1071.53.001, 1060.01.008, 1100.30.060, 1020.41.170
Primary DI / UDI-DI
08698940974998, 08698940937979, 08698940951623, 08698940945318, 08698940937313, 08698940937351, 08698940969338, 08698940974769, 08698940938044, 08698940975100, 08698940937160, 08698940937009, 08698940931656, 08698940967440, 08698940963794, 08698940967822, 08698940973533, 08698940968416, 08698940973540, 08698940954051, 08698940967464, 08698940973502, 08698940971492, 08698940972888, 08698940967457, 08698940969055, 08698940958448, 08698940971454, 08698940973519, 08698940974882, 08698940931595, 08698940968881, 08698940973694, 08698940964623, 08698940967495, 08698940905732, 08698940900324, 08698940973557, 08698940961851, 08698940973472, 08698940915212, 08698940954013, 08698940973496, 08698940970242, 08698940973595, 08698940975049, 08698940973199, 08698940973205
Basic UDI-DI
B-08698940974998, B-08698940937979, B-08698940951623, B-08698940945318, B-08698940937313, B-08698940937351, B-08698940969338, B-08698940974769, B-08698940938044, B-08698940975100, B-08698940931656, B-08698940967440, B-08698940963794, B-08698940937160, B-08698940967822, B-08698940973533, B-08698940968416, B-08698940973540, B-08698940954051, B-08698940967464, B-08698940973502, B-08698940937009, B-08698940971492, B-08698940972888, B-08698940967457, B-08698940969055, B-08698940958448, B-08698940971454, B-08698940973519, B-08698940974882, B-08698940931595, B-08698940968881, B-08698940973694, B-08698940964623, B-08698940967495, B-08698940905732, B-08698940900324, B-08698940973557, B-08698940961851, B-08698940973472, B-08698940915212, B-08698940954013, B-08698940973496, B-08698940970242, B-08698940973595, B-08698940975049, B-08698940973199
FDA Product Code
LXH
EMDN Code
L0999, L090999, L091199
GMDN Term
Orthopaedic prosthesis implantation positioning instrument, reusable
Device Class
Class I EUDAMEDGUDID
Class IIa EUDAMED
Regulation Number
888.4540
EU market of registration
France
Austria
Türkiye
Italy
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 I
Class IIa
GUDID
Class I

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
  • Prescription Use NoGUDIDYesGUDID
  • Premarket Exempt
  • Lot / Batch Number

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