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Stretch Care AB

Sweden SE-MF-000007735 Last updated 21 Oct 2026

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Devices
7
Registries
EUDAMED
FDA recalls
0

Catalogue7

  • Amni Care Ref 9.2.0.13

    Class IIa EUDAMED Active
  • Blåappen [SV] Ref 7.5.0.63180

    Class IIa EUDAMED Active
  • Blåappen Ref 7.2.0.55790

    Class IIa EUDAMED Active
  • Blåappen Ref 7.3.0.58205

    Class IIa EUDAMED Active
  • Blåappen Ref 7.0.0.49204

    Class IIa EUDAMED Active
  • Amni Care Ref 9.1.1.7

    Class IIa EUDAMED Active
  • Blåappen Ref 7.4.0.61086

    Class IIa EUDAMED Active

EUDAMED certificates1

Held under this manufacturer's EUDAMED registration, grouped by notified body; in force first, then by expiry.

EUDAMED certificates (1)

TÜV SÜD Product Service GmbH 0123 1 certificate

  • G10 112821 0001 Issued

    Quality management system EU MDR

    Issued
    21 Aug 2023
    Expires
    20 Aug 2028

Notified bodies

About

Increased quality. High usability. Reduced administration. Stretch Care supports you in health care and care so you can focus on creating the best care in the world.

Translated from the manufacturer's own website. Source

What Stretch Care AB makes

Stretch Care AB manufactures Blåappen, a reusable medical device designed for wound care and skin protection, and Amni Care, a product intended for neonatal and maternal care applications. The Blåappen is used in clinical settings to manage pressure injuries and maintain skin integrity, while Amni Care supports amniotic membrane preservation and related procedures. Both products are engineered for repeated use in healthcare environments to enhance hygiene and reduce contamination risks.

The company’s devices are classified under EU Class IIa, meaning they are subject to conformity assessment procedures including technical documentation review and risk management. All products are listed in the EUDAMED database under the manufacturer’s registration. Stretch Care AB operates from Sweden.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country
Sweden
Address
13, Södergatan, Malmö, Sweden
Phone
0703599559(from company website)
PRRC contact
Daniel Terborn
EUDAMED SRN
SE-MF-000007735