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Medical dry film

by Jiangsu Taike Medical Technology Co., Ltd EUDAMED

Active European Union

Ref TK-880-16K, TK-680-16K, TK-880（10×12）in, TK-808（14×17）in, TK-680-A3, TK-680-A4, TK-680（11×14）in, TK-880-A3, TK-410-B5, TK-410（10×12）in, TK-808-16K, TK-880（11×14）in, TK-410-A4, TK-410（8×10）in, TK-880（13×17）in, TK-680-B5, TK-410（10×14）in, TK-808（10×14）in, TK-680（13×17）in, TK-808（13×17）in, TK-808（10×12）in, TK-680（10×14）in, TK-880-B5, TK-410（11×14）inModel TK-410（14×17）in、TK-410（13×17）in、TK-410（11×14）in、TK-410（10×14）in、TK-410（10×12）in、TK-410（8×10）in、TK-410-A3、TK-410-A4、etc

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697502290TKMDFMS Basic UDI-DIDate3 Jun 2024RegisteredStatusActive

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  • Withdrawn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
Medical dry film
Model / Reference
TK-410（14×17）in、TK-410（13×17）in、TK-410（11×14）in、TK-410（10×14）in、TK-410（10×12）in、TK-410（8×10）in、TK-410-A3、TK-410-A4、etc, TK-880-16K, TK-680-16K, TK-880（10×12）in, TK-808（14×17）in, TK-680-A3, TK-680-A4, TK-680（11×14）in, TK-880-A3, TK-410-B5, TK-410（10×12）in, TK-808-16K, TK-880（11×14）in, TK-410-A4, TK-410（8×10）in, TK-880（13×17）in, TK-680-B5, TK-410（10×14）in, TK-808（10×14）in, TK-680（13×17）in, TK-808（13×17）in, TK-808（10×12）in, TK-680（10×14）in, TK-880-B5, TK-410（11×14）in
Primary DI / UDI-DI
06975022900284, 06975022900185, 06975022900246, 06975022900307, 06975022900161, 06975022900178, 06975022900123, 06975022900260, 06975022900093, 06975022900048, 06975022900383, 06975022900222, 06975022900079, 06975022900055, 06975022900215, 06975022900192, 06975022900031, 06975022900338, 06975022900116, 06975022900314, 06975022900345, 06975022900130, 06975022900291, 06975022900024
Basic UDI-DI
697502290TKMDFMS
EMDN Code
Z130101 General purpose x-ray films
Device Class
Class I
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000041908
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

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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