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Disposable NIBP Cuff

by Solaris Medical Technology, Inc United States(FDA 510(k) applicant) EUDAMED

Ref C1015Model C1014 EMDN Z1203020285

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number6900234CUF001JV Basic UDI-DIDate13 May 2026RegisteredStatusActive

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  • Withdrawn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 25 Oct 2026

Device Name
Blood pressure cuff, single use
Model / Reference
C1014, C1015
Primary DI / UDI-DI
06900234300423
Basic UDI-DI
6900234CUF001JV
EMDN Code
Z1203020285 Multi-parameter monitors - consumables
Device Class
Class I
Market of Registration
France

Manufacturer details

EUDAMED SRN
CN-MF-000038492
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Solaris Medical Technology, Inc.

See all devices from Solaris Medical Technology, Inc. →

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 (1)

  • EUDAMED 06900234300423|6900234CUF001JV 61 fields · synced 25 Oct 2026