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Pine Smart Baby Diaper

by Arkan Grup Sağlık Ürünleri A.Ş. 9 variants

Ref PSJN.05-RC-5, PSJN.05-T-15, PSXL.06-E-5, PSMN.02-RC-5, PSMD.03-T-22, PSMX.04-E-5, PSMN.02-E-5, PSXL.06-T-16, PSJN.05-L-18, PSMD.03-R-22, PSMX.04-T-20, PSMX.04-R-20, PSJN.05-R-18, PSXL.06-L-16, PSMD.03-RC-5, PSXL.06-RC-5, PSJN.05-E-5, PSMX.04-RC-5, SXL.06-R-16, PSMD.03-E-5, PSMX.04-T-5, PSMN.02-R-24, PSJN.05-BS-5, PSMX.04-HRİ-5, PSJN.05-SB-5, PSXL.06-BS-5, PSMD.03-BS-5, PSMN.02-BS-5, PSJN.05-HRİ-5, PSMX.04-SB-5, PSMX.04-BS-5, PSMD.03-HRİ-5, PSXL.06-SB-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 Date8 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  • Withdrawn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

Trade Name
Pine Smart Baby Diaper
Pine Smart Diaper
Model / Reference
PSJN.05-RC-5, PSJN.05-T-15, PSXL.06-E-5, PSMN.02-RC-5, PSMD.03-T-22, PSMX.04-E-5, PSMN.02-E-5, PSXL.06-T-16, PSJN.05-L-18, PSMD.03-R-22, PSMX.04-T-20, PSMX.04-R-20, PSJN.05-R-18, PSXL.06-L-16, PSMD.03-RC-5, PSXL.06-RC-5, PSJN.05-E-5, PSMX.04-RC-5, SXL.06-R-16, PSMD.03-E-5, PSMX.04-T-5, PSMN.02-R-24, PSJN.05-BS-5, PSMX.04-HRİ-5, PSJN.05-SB-5, PSXL.06-BS-5, PSMD.03-BS-5, PSMN.02-BS-5, PSJN.05-HRİ-5, PSMX.04-SB-5, PSMX.04-BS-5, PSMD.03-HRİ-5, PSXL.06-SB-5
Primary DI / UDI-DI
08594188780158, 08699096963850, 08699096964635, 08594188780127, 08699096963737, 08699096964611, 08699096964598, 08699096963768, 08699096963959, 08699096963683, 08699096963744, 08699096963690, 08699096963706, 08699096963966, 08594188780134, 08594188780165, 08699096964628, 08594188780141, 08699096963713, 08699096964604, 08699096963843, 08699096963676, 08699096964970, 08699096968206, 08699096968060, 08699096964987, 08699096964956, 08699096964949, 08699096968213, 08699096968053, 08699096964963, 08699096968190, 08699096968077
Basic UDI-DI
869909696PS9Y
Direct Marketing DI
08594188780158
08699096963850
08699096964635
08594188780127
08699096963737
08699096964611
08699096964598
08699096963768
08699096963959
08699096963683
08699096963744
08699096963690
08699096963706
08699096963966
08594188780134
08594188780165
08699096964628
08594188780141
08699096963713
08699096964604
08699096963843
08699096963676
EMDN Code
W0101060299 Urine testing - other
Device Class
Class A
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000027138

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Properties

  • Near-Patient Testing
  • Professional Testing
  • New Device NoEUDAMEDYesEUDAMED

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