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Amni Care

by Stretch Care AB Sweden EUDAMED

Ref 9.1.1.7, 9.0.0.9

EMDN Z12040192

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number735012568Blaappen79 Basic UDI-DIDate13 Sep 2023RegisteredStatusWithdrawn No longer placed on the EU market

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Withdrawn
  • Not covered

European Union — CE/MDR Withdrawn

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Blåappen
Model / Reference
9.1.1.7, 9.0.0.9
Primary DI / UDI-DI
07350125680148, 07350125680131
Basic UDI-DI
735012568Blaappen79
Direct Marketing DI
07350125680148
07350125680131
EMDN Code
Z12040192 General medicine diagnosis and monitoring instruments - medical device software
Device Class
Class IIa
Market of Registration
Sweden

Manufacturer details

EUDAMED SRN
SE-MF-000007735

Other devices from Stretch Care AB

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 (2)

  • EUDAMED dffeb7fd-02d4-4386-8aa4-a84e35dc59a6 61 fields · synced 24 Oct 2026
  • EUDAMED 07350125680131|735012568BLAAPPEN79 61 fields · synced 18 May 2026