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Pjama

by Pjama AB Sweden EUDAMEDGUDID

Ref 4107 Product code KPNEMDN U070299

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number735007844alarmsystemEG Basic UDI-DIDate11 May 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number07350078441773 UDI-DIDate15 Nov 2023ListedStatusIn distribution

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/MDR Active
  • 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 Bedwetting Alarm System
Model / Ref / Catalog
4107, Treatment Boxers Underwear darkblue- Size 134/140
Primary DI / UDI-DI
07350078441773
Basic UDI-DI
735007844alarmsystemEG
Direct Marketing DI
07350078441773
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
4107
GUDID
Treatment Boxers Underwear darkblue- Size 134/140
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 (2)

  • EUDAMED 48ea039e-0cd2-4a8a-a165-f5f12211b96f 61 fields · synced 22 Oct 2026
  • FDA UDI 81973e55-fdf7-4c65-a807-cb96a57004e5 35 fields · synced 30 May 2026