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Amd

by Nantong Fuhua Medical Packing Co., Ltd EUDAMED

Active European Union

Ref FR50

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697094146AMD-STER-ROLSP Basic UDI-DIDate23 Aug 2023RegisteredStatusActive

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  • Withdrawn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
Flat Sterilization Reel
Model / Reference
FR50
Primary DI / UDI-DI
06970941460239
Basic UDI-DI
697094146AMD-STER-ROLSP
EMDN Code
S01020101 Flat sterilisation reels, paper/plastic film
Device Class
Class I
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
CN-MF-000035046
Authorised representative
Hopeway B.V. NL-AR-000035002

Other devices from Nantong Fuhua Medical Packing Co., Ltd

  • Amd

    Class I

  • Amd

    Class I

Properties

  • Reprocessed

Other properties (12)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: 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