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M Dialysis AB

Sweden SE-MF-000017466 Last updated 23 Oct 2026

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Devices
24
Registries
EUDAMEDGUDIDFDA
FDA recalls
0

Catalogue24

  • 8050092 Ref 8050092

    Class IIa EUDAMED Active
  • 8010670 Ref 8010670

    Class IIa EUDAMED Active
  • 8010514 Ref 8010514

    Class IIa EUDAMED Active
  • Forceps Ref P000056

    Class I EUDAMED Active
  • 8010651 Ref 8010651

    Class IIa EUDAMED Active
  • Microvials Ref P000001

    Class A EUDAMEDFDA UDI Active
  • 8050191 Ref 8050191

    Class IIa EUDAMED Active
  • 8010671 Ref 8010671

    Class IIa EUDAMED Active
  • 8050151 Ref 8050151

    Class IIa EUDAMED Active
  • Splitable Introducer SI-2 Ref 8010343

    Class IIa EUDAMED Active
  • 8050091 Ref 8050091

    Class IIa EUDAMED Active
  • 8050093 Ref 8050093

    Class IIa EUDAMED Active
  • 8010226 Ref 8010226

    Class IIa EUDAMED Active
  • Microvials Ref P000154

    Class A EUDAMEDFDA UDI Active
  • 8010509 Ref 8010509

    Class IIa EUDAMED Active
  • P000127 Ref P000127

    Class IIa EUDAMED Active
  • 106 Syringe Ref 8010191

    Class I EUDAMEDFDA UDI Active
  • 8050090 Ref 8050090

    Class IIa EUDAMED Active
  • P000003 Ref P000003

    Class IIa EUDAMEDFDA UDI Active
  • ISCUS flex Microdialysis Analyzer Ref 8003295

    Class A EUDAMEDFDA UDI Active
  • P000034 Ref P000034

    Class IIa EUDAMED Active
  • P000151 Ref P000151

    Class IIa EUDAMED Active
  • 8010650 Ref 8010650

    Class IIa EUDAMED Active
  • Tunnelating Needle Ref P000055

    Class I EUDAMED Active

EUDAMED certificates3

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

EUDAMED certificates (3)

Intertek Medical Notified Body AB 2862 3 certificates

  • 28620170242 Issued

    Quality management system EU MDR

    Issued
    30 Aug 2024
    Expires
    18 Dec 2028
  • 28620178540 Issued

    Quality management system EU MDR

    Issued
    10 Jun 2024
    Expires
    18 Dec 2028
    Valid from
    30 Aug 2024
  • 28620178542 Issued

    Quality management system EU MDR

    Issued
    30 Aug 2024
    Expires
    18 Dec 2028

FDA establishments1

Registered with the FDA under this company group, matched by name.

  • M Dialysis Inc. US

Information

Country
Sweden
Address
43, Hammarby Fabriksväg, Stockholm, Sweden
Phone
+46 8 470 10 20
PRRC contact
Ebba Cederqvist Molander
EUDAMED SRN
SE-MF-000017466
FDA FEI number
3003733874