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Shelly

by TSE spol. s r.o. Czech Republic EUDAMED

Ref 11FY95028GModel SI-610-1 EMDN Z1208040301

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08594216240005 Basic UDI-DIDate28 May 2026RegisteredStatusActive

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  • Withdrawn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 25 Oct 2026

Model / Reference
SI-610-1, 11FY95028G
Primary DI / UDI-DI
08594216240005
Basic UDI-DI
B-08594216240005
EMDN Code
Z1208040301 Fixed neonatal incubators
Device Class
Class IIb
Market of Registration
Czechia

Manufacturer details

EUDAMED SRN
CZ-MF-000026442

Other devices from TSE spol. s r.o.

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 (1)

  • EUDAMED 66f277c3-e146-4759-b3ee-591c23fc8cd0 61 fields · synced 25 Oct 2026