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Nylex

by Jiangsu NewValue Medical Products Co., Ltd. EUDAMED

Active European Union

Ref 605350Model Silicone-Border Lite

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697020682FDSBLSFL Basic UDI-DIDate5 Nov 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  • Withdrawn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
Foam Dressing
Model / Reference
Silicone-Border Lite, 605350
Primary DI / UDI-DI
06970206824196
Basic UDI-DI
697020682FDSBLSFL
Unit of Use DI
26970206824190
EMDN Code
M04010102 Polyurethane (or other material) adhesive dressings, with absorbent pad
Device Class
Class IIb
Market of Registration
France

Manufacturer details

EUDAMED SRN
CN-MF-000008202
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Jiangsu Newvalue Medical Products Co., Ltd.

See all devices from Jiangsu Newvalue Medical Products Co., Ltd. →

Properties

  • Sterile

Other properties (12)

  • 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