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4K UHD Arthroscope

by Scivita Medical Technology Co., Ltd. United States EUDAMED

Ref 4K4000Model 4K4000,4K4030,4K4070

EMDN Z12021101

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697138125005A8B Basic UDI-DIDate3 Nov 2021RegisteredStatusActive

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
4K4000, 4K4030, 4K4070
Primary DI / UDI-DI
06971381250282
Basic UDI-DI
697138125005A8B
Direct Marketing DI
06971381250282
EMDN Code
Z12021101 Arthroscopes
Device Class
Class IIa
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000010305
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Scivita Medical Technology Co., Ltd.

See all devices from Scivita Medical Technology Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Reusable
Other properties (12)
  • Sterile: No
  • Implantable: 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 92e4c78b-036f-4a71-8f46-61838431684a 61 fields · synced 22 Oct 2026