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KangLi

by Suzhou Kangli Orthopaedics Instrument Co., Ltd. EUDAMEDGUDID

Active European Union EUDAMED: not on the EU market

Ref T5816540Model Non-sterile Spinal Systems(KSS-II, III Lumbar)

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number690295900030FD Basic UDI-DIDate25 Aug 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number06937762171409 UDI-DIDate3 Sep 2016ListedStatusListed GUDID: not in commercial distribution

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

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.

Recalls

0 recalls · FDA

No FDA recalls on record, checked 24 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
KangLi EUDAMED
KangLi Pedicle Screw Spinal System GUDID
Generic Name
Spinal bone screw, non-bioabsorbable
Device Name
Non-sterile Spinal Systems
Model / Ref / Catalog
Non-sterile Spinal Systems(KSS-II, III Lumbar), T5816540
Description
KSS 6.0 U-Pedicle Screw φ6.5×40mm
Primary DI / UDI-DI
06937762171409
Basic UDI-DI
690295900030FD
Direct Marketing DI
06937762171409
510(k) Number
FDA Product Code
MNH, MNI
EMDN Code
P09070302 Thoracolumbosacral fixation systems
GMDN Term
Spinal bone screw, non-bioabsorbable
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
888.3070
GUDID distribution status
Not in Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization
Size
Length — 40 Millimeter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
GUDID
Class II
SterileEUDAMED
No
GUDID
Yes

Manufacturer details

EUDAMED SRN
CN-MF-000016075
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Suzhou Kangli Orthopaedics Instrument Co., Ltd.

Properties

  • Sterile NoEUDAMEDYesGUDID
  • Single Use
  • Implantable
  • Reprocessed
  • Sutures
  • Lot / Batch Number
  • Manufacturing Date

Other properties (18)

  • Reusable: No
  • Contains Latex: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: 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
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No