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Orthopedic Instruments

by Shanghai Tianle Rehabilitation Assistive Device Co., Ltd EUDAMED

Active European Union

Ref TLQT-3.0-49-XGPModel TLQT-3.0-49-XGP、TLQT-4.0-49-XGP、 TLQT-5.0-49-XGP、TLQT-6.0-44-XGP、TLSM-3.0-49-XGP、TLSM-4.0-49-XGP、TLSM-5.0-49-XGP、TLSM-6.0-49-XGP、TLXXZ-1.8/3.0-21-54.7-2GP、etc

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697528913OI001KG Basic UDI-DIDate29 Sep 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
Orthopedic Instruments
Model / Reference
TLQT-3.0-49-XGP、TLQT-4.0-49-XGP、 TLQT-5.0-49-XGP、TLQT-6.0-44-XGP、TLSM-3.0-49-XGP、TLSM-4.0-49-XGP、TLSM-5.0-49-XGP、TLSM-6.0-49-XGP、TLXXZ-1.8/3.0-21-54.7-2GP、etc, TLQT-3.0-49-XGP
Primary DI / UDI-DI
06975289130011
Basic UDI-DI
697528913OI001KG
EMDN Code
K01020101 Minimally invasive surgery dissectors, single-use
Device Class
Class I
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000049450
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Properties

Other properties (13)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: 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