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Pine Smart Diaper

by Arkan Grup Sağlık Ürünleri A.Ş. 4 variants

Ref PSXL.06-HRİ-5

Active European Union

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number869909696PS9Y Basic UDI-DI 08699096968220UDI-DIDate8 Sep 2024RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDR Active

Specification

EUDAMED

Device Name
Pine Smart Baby Diaper
Model / Reference
PSXL.06-HRİ-5
Primary DI / UDI-DI
08699096968220
Basic UDI-DI
869909696PS9Y
EMDN Code
W0101060299 Urine testing - other
Device Class
Class A
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000027138

Other devices from Arkan Grup Sağlık Ürünleri A.Ş.

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Properties

  • Near-Patient Testing
  • Professional Testing
  • New Device

Other properties (8)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No