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Q-Med AB

Sweden SE-MF-000008549 Last updated 23 Oct 2026

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Devices
22
Registries
EUDAMEDFDA PMAFDA
FDA recalls
0

Catalogue22

EUDAMED certificates4

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

EUDAMED certificates (4)

Notified body 0344 4 certificates

  • 2268181TD04 Issued

    Technical documentation EU MDR

    Issued
    30 Jul 2026
    Expires
    1 Jul 2031
  • 2268181TD02 Issued

    Technical documentation EU MDR

    Issued
    3 Dec 2025
    Expires
    1 Dec 2030
  • 2268181CE02 Issued

    Quality management system EU MDR

    Issued
    3 Dec 2025
    Expires
    1 Aug 2030
  • 2268181CE04 Issued

    Quality management system EU MDR

    Issued
    30 Jul 2026
    Expires
    1 Aug 2030

Notified bodies

  • Notified body 0344

What Q-Med AB makes

Q-Med AB manufactures injectable dermal fillers and skinboosters, including products such as Restylane Skinboosters Vital Light Lidocaine, Restylane Skinboosters Vital Lidocaine, Restylane Kysse, Restylane Lyft Lidocaine, New-Fill, Restylane Injectable Gel, Restylane Refyne and Defyne Injectable Gels, Sculptra and Sculptra Aesthetic, Restylane, Perlane, Restylane L, Perlane L, and Restylane Volyme.

These devices are classified as Class III medical devices and are listed in the EUDAMED and FDA PMA registries. The company is based in Sweden (SE).

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

Frequently asked questions

What does Q-Med AB manufacture?

Q-Med AB manufactures injectable dermal fillers and skinboosters, including products such as Restylane Skinboosters Vital Light Lidocaine, Restylane Skinboosters Vital Lidocaine, Restylane Kysse, Restylane Lyft Lidocaine, New-Fill, Restylane Injectable Gel, Restylane Refyne and Defyne Injectable Gels, Sculptra and Sculptra Aesthetic, Restylane, Perlane, Restylane L, Perlane L, and Restylane Volyme. These are all injectable gel-based devices intended for dermal implantation.

Where is Q-Med AB based?

Q-Med AB is based in Sweden, as indicated by the country code SE in the manufacturer data. This specifies the country where the company is legally registered and operates from for regulatory purposes.

In which regulatory registries are Q-Med AB's devices listed?

Q-Med AB's devices are listed in the EUDAMED and FDA PMA registries. EUDAMED is the European database for medical devices, and FDA PMA refers to the U.S. Food and Drug Administration's Premarket Approval database for high-risk devices.

How are Q-Med AB's devices classified?

Q-Med AB's devices are classified as Class III medical devices. This classification indicates they are high-risk devices, typically due to their intended use in dermal implantation and prolonged contact with the body, requiring the most stringent regulatory controls.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
Sweden
Address
21, Seminariegatan, Uppsala, Sweden
Website
galderma.com
PRRC contact
Pernilla Styf
EUDAMED SRN
SE-MF-000008549
FDA FEI number
3003347293
DUNS number
355371873