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Pjama

by Pjama AB Sweden EUDAMEDGUDID

Ref 9032 Pjama- Speaker, 9032 Product code KPNEMDN U070299

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number07350078441315 UDI-DIDate15 Nov 2023ListedStatusIn distribution
European UnionCE/MDD EUDAMED NumberB-07350078441315 Basic UDI-DIDate5 Oct 2023RegisteredStatusActive

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/MDD Expiring
  • United States GUDID listing Listed

Recalls: none on record (FDA, checked 22 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · GUDID · synced 22 Oct 2026

Generic Name
Incontinence sensor/alarm
Device Name
Pjama- Speaker
Pjama Bedwetting Alarm System
Model / Ref / Catalog
9032 Pjama- Speaker, 9032, Pjama Speaker
Primary DI / UDI-DI
07350078441315
Basic UDI-DI
B-07350078441315, 735007844alarmsystemEG
Direct Marketing DI
07350078441315
FDA Product Code
KPN
EMDN Code
U070299 External devices for the treatment of incontinence - other
GMDN Term
Incontinence sensor/alarm
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
876.2040
Market of Registration
Sweden
Commercial Distribution
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
9032 Pjama- Speaker
9032
GUDID
Pjama Speaker
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

EUDAMED SRN
SE-MF-000016973

Other devices from Pjama AB

  • Pjama

    Class I

  • Pjama

    Class I

  • Pjama

    Class I

  • Pjama

    Class I

  • Pjama

    Class I

  • Pjama

    Class I

See all devices from Pjama AB →

Properties & raw data

Show properties, registry sources and raw records
  • Over-the-Counter
  • Premarket Exempt
  • Manufacturing Date
Other properties (21)
  • Sterile: No
  • Single Use: 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
  • Prescription Use: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Lot / Batch Number: No
  • Serial Number: No
  • Expiration Date: No

Sources (3)

  • EUDAMED 15660ca2-699e-4abe-90ee-6c2fb7df2747 61 fields · synced 22 Oct 2026
  • EUDAMED 07350078441315|735007844ALARMSYSTEMEG 61 fields · synced 18 May 2026
  • FDA UDI 1cf65f06-d9aa-4257-8a25-c0ad4e0cdb91 34 fields · synced 30 May 2026