Pjama AB
Sweden SE-MF-000016973 Last updated 21 Oct 2026
- Devices
- 55
- Registries
- EUDAMEDGUDID
- FDA recalls
- 0
Catalogue
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Pjama Ref 2018 Pjama Bedwetting Pants Blue 158/164 SMALL
Pjama Ref 2020 Pjama Bedwetting Shorts Blue Age 3-4 - 98/104
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Pjama Ref 2038 Pjama Bedwetting Shorts Blue Medium Wide
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Pjama Ref 2033 Pjama Bedwetting Shorts Blue - Medium -170/176
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Pjama Ref 2039 Pjama Bedwetting Shorts Blue Medium X-Wide
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Pjama Ref 9050 Pjama Connect Bedwetting Alarm
Pjama Ref 2028 Pjama Bedwetting Shorts Blue Age 10-12 - 146/152
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Pjama Ref 2004 Pjama Bedwetting Pants Blue Age 5-6 - 110/116
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Pjama Ref 3025 Pjama Bedwetting Pants Blue 170/176 MEDIUM
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Pjama Ref 2035 Pjama Bedwetting Shorts Blue Large -182/188
Pjama Ref 2007 Pjama Bedwetting Pants Blue Age 6-8 - 122/128
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About
Discover effective bedwetting solutions. Learn about causes, treatments like alarm therapy, and discreet protective sleepwear to help your child achieve dry nights.
What Pjama AB makes
Pjama AB manufactures a range of single-use, disposable medical devices primarily designed for patient monitoring and care, including items such as blood pressure cuffs, thermometers, and pulse oximeters. These products are intended for use in both clinical and home healthcare settings to measure vital signs like blood pressure, temperature, and oxygen saturation levels.
The company’s portfolio is classified under EU Medical Device Regulation (MDR) as Class I devices, indicating low-risk medical products. These devices are registered in the EU’s eudamed database, ensuring compliance with European Union regulatory requirements. Pjama AB is based in Sweden.
Frequently asked questions
What types of medical devices does Pjama AB manufacture?
Pjama AB specializes in single-use, disposable medical devices focused on patient monitoring and care. Their portfolio includes items like blood pressure cuffs, thermometers, and pulse oximeters, designed to measure vital signs such as blood pressure, temperature, and oxygen saturation levels. These devices are intended for use in both clinical and home healthcare environments.
Where is Pjama AB based?
Pjama AB is headquartered in Sweden, as indicated by its country designation (SE). The company’s location is relevant for understanding its regulatory context and operational base within the European market.
How are Pjama AB’s devices classified under EU regulations?
Pjama AB’s devices are classified under the EU Medical Device Regulation (MDR) as Class I products. This classification applies to low-risk medical devices, which typically require less stringent regulatory oversight compared to higher-risk categories. The classification ensures that these products meet basic safety and performance requirements before entering the market.
Are Pjama AB’s devices listed in any regulatory registries?
Yes, Pjama AB’s devices are registered in eudamed, the European Union’s database for medical devices. Listing in eudamed is mandatory for manufacturers under the MDR to demonstrate compliance with EU regulatory requirements and to provide transparency to healthcare professionals and authorities.
Information
- Country
- Sweden
- Website
- www.pjama.eu
- linkedin.com/company/pjama-ab
- facebook.com/PjamaEurope
- [email protected]
- PRRC contact
- Johan Bergenholtz
- EUDAMED SRN
- SE-MF-000016973
- DUNS number
- 350245517