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Platelet additive solution

by Maco Pharma 16 variants

Part of a family of 16 devices: see the family page

Ref SSP4025R

Platelet additive solution (SSP4025R) is a Class III device made by Maco Pharma, registered in EUDAMED on 22 Apr 2024 (Basic UDI-DI 356705SSP1MN) with CE/MDR certificate 39532 valid until 16 Jan 2029, active as of 25 Oct 2026.

Active European Union

CE MDR

Valid until

16 Jan 2029

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier GMED SAS

Trust

Unverified

Source EUDAMED, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number39532 Date8 Oct 2026IssuedStatusActive EUDAMED: not on the EU market expires 16 Jan 2029

Official records

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 39532 Active Amended

    Technical documentation EU MDR

    Certifier
    GMED SAS 0459
    Issued
    8 Oct 2026
    Expires
    16 Jan 2029
    Reason
    Other

Timeline

3 dated events

  1. Registered EUDAMED 356705SSP1MN
  2. Certificate issued EUDAMED 39532
  3. Certificate expires EUDAMED 39532

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device name
Platelet Additive Solution SSP+
Model / reference
SSP4025R
Primary DI / UDI-DI
03567050072144
Basic UDI-DI
356705SSP1MN
EMDN code
B0199 Blood bags and kits - other
Device class
Class III
EU registration type
Standard device

Manufacturer details

EUDAMED SRN
FR-MF-000001657

Other devices from Maco Pharma

See all devices from Maco Pharma →

Properties

  • Supplied sterile
  • Incorporates a medicinal substance
Other properties (12, all answered No)