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Disposable Fascial Closure Systems

by ChangZhou 3R Medical Device Technology Co., Ltd EUDAMED

Active European Union

Ref SRDFCS-A-20

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-06973118370034 Basic UDI-DIDate29 Jul 2025RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
Disposable Fascial Closure Systems
Model / Reference
SRDFCS-A-20
Primary DI / UDI-DI
06973118370034
Basic UDI-DI
B-06973118370034
EMDN Code
K01020116 Endoscopic tissue suture approximators, single - use
Device Class
Class IIa
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000001123
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from ChangZhou 3R Medical Device Technology Co., Ltd

See all devices from ChangZhou 3R Medical Device Technology Co., Ltd →

Properties

  • Sterile

Other properties (10)

  • Implantable: No
  • Reusable: 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