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Stowood Black Flash

by Stowood Scientific Instruments Ltd. United Kingdom EUDAMED

Ref BF-R, BFP-R EMDN Z12100501

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-05060504340052 Basic UDI-DIDate11 Jul 2023RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Trade Name
Stowood Black Flash
Stowood Black Flash Plus
Device Name
Black Flash
Black Flash Plus
Model / Reference
BF-R, BFP-R
Primary DI / UDI-DI
05060504340052, 05060504340069
Basic UDI-DI
B-05060504340052, B-05060504340069
EMDN Code
Z12100501 Polysomnographs
Device Class
Class IIa
Market of Registration
Ireland

Manufacturer details

EUDAMED SRN
GB-MF-000035931
Authorised representative
Medaptivo EU Ltd. IE-AR-000044302

Other devices from Stowood Scientific Instruments Ltd.

Properties & raw data

Show properties, registry sources and raw records
  • Measuring Function
Other properties (10)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Incorporates Medicinal Product: No

Sources (2)

  • EUDAMED d94bab49-c677-40a1-9e70-7c0f6c21b6bf 61 fields · synced 22 Oct 2026
  • EUDAMED 05060504340069|B-05060504340069 61 fields · synced 18 May 2026