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Medical Dry Laser Film

by Smart Health Biotech (Guangxi) Co., Ltd. China EUDAMED

Ref 26349 10021, 26349 10019, 26349 10018Model SM-HLJ-C

EMDN Z130101

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69263491SDF58 Basic UDI-DIDate7 Mar 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
SM-HLJ-C, 26349 10021, 26349 10019, 26349 10018
Primary DI / UDI-DI
06926349100215, 06926349100192, 06926349100185
Basic UDI-DI
69263491SDF58
EMDN Code
Z130101, Z11079085,Z130101
Device Class
Class I
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
CN-MF-000040855
Authorised representative
Lotus NL B.V. NL-AR-000000121

Properties & raw data

Show properties, registry sources and raw records
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

Sources (3)

  • EUDAMED bbf48e79-6d0a-4e51-b2f6-30af3149b623 61 fields · synced 22 Oct 2026
  • EUDAMED 06926349100192|69263491SDF58 61 fields · synced 17 May 2026
  • EUDAMED 06926349100185|69263491SDF58 61 fields · synced 17 May 2026