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Neko Health AB

Sweden SE-MF-000045605 Last updated 23 Oct 2026

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Devices
10
Registries
EUDAMEDGUDIDFDA 510(k)FDA
FDA recalls
0

Catalogue10

  • Neko Health Spectrum-2 Ref Spectrum-2

    Class II FDA UDI Active

  • Echo-2 Ref K254240

    Class II FDA 510(k) Active

  • Echo-2 Ref 102556

    Class I EUDAMEDFDA UDI Active

  • Positioner-1 Ref 102858

    Class I EUDAMEDFDA UDI Active

  • Spectrum-2 Ref 100515

    Class I EUDAMED Active

  • Bdem-01 Ref K9302000A

    Class I EUDAMED Active

  • Derma-2 Ref 102040

    Class I EUDAMEDFDA UDI Active

  • Spectrum-1 Ref 101718

    Class I EUDAMED Active

  • Derma-1 Ref 101630

    Class I EUDAMED Active

  • Echo-1 Ref 101725

    Class I EUDAMED Active

EUDAMED certificates1

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

EUDAMED certificates (1)

Notified body 3022 1 certificate

  • SCAR-28.2.1.0 Issued

    Quality management system EU MDR

    Issued
    20 Oct 2026
    Expires
    19 Oct 2031

Related companies

Notified bodies

  • Notified body 3022

Information

Country
Sweden
Address
19, Svärdvägen, Danderyd, Sweden
Phone
+46 8 502 427 76
PRRC contact
Per Sundström
EUDAMED SRN
SE-MF-000045605
FDA FEI number
3042165671
DUNS number
353319894