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Apothi-Tech

by Jiangsu NewValue Medical Products Co., Ltd. China EUDAMED

Ref LE1687Model Silicone-Border Lite

EMDN M04010102

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697020682FDSBLSFL Basic UDI-DIDate5 Nov 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Foam Dressing
Model / Reference
Silicone-Border Lite, LE1687
Primary DI / UDI-DI
03664788007056
Basic UDI-DI
697020682FDSBLSFL
Unit of Use DI
23664788007050
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 & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED ec5638c6-1dea-4a26-9be0-1fd42bded5d7 61 fields · synced 24 Oct 2026