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Single-use Flexible Ureteroscope

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

Ref SUV-2B-BModel SUV-(1A-B,1A-P,2A-B,2A-P,2B-B,2B-P,2C-B,2C-P,3A-B,3C-B,4A-B,4C-B,1A-BF, 2A-BF, 2B-BF, 2C-BF, 3C-BF, 4C-BF, 1F-BF, 2F-BF), SUVB-(1F-BF , 2F-BF),SUVC-(1F-BF, 2F-BF), SUVG-(1F-BF, 2F-BF),SUVI-1F-BF, SUVE-1F-BF EMDN Z12020713

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697138125007A8H Basic UDI-DIDate3 Nov 2021RegisteredStatusActive

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  • Withdrawn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 · synced 23 Oct 2026

Model / Reference
SUV-(1A-B, 1A-P, 2A-B, 2A-P, 2B-B, 2B-P, 2C-B, 2C-P, 3A-B, 3C-B, 4A-B, 4C-B, 1A-BF, 2A-BF, 2B-BF, 2C-BF, 3C-BF, 4C-BF, 1F-BF, 2F-BF), SUVB-(1F-BF, SUVC-(1F-BF, SUVG-(1F-BF, SUVI-1F-BF, SUVE-1F-BF, SUV-2B-B
Primary DI / UDI-DI
06971381254211
Basic UDI-DI
697138125007A8H
Direct Marketing DI
06971381254211
EMDN Code
Z12020713 Ureterorenoscopes
Device Class
Class IIa
Market of Registration
Belgium

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
  • 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 77b1fee6-3333-4e79-864d-d0062361b036 61 fields · synced 23 Oct 2026