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Pro45S

by Puma Srl Italy EUDAMED

Ref PRO 28F, pro 28FModel Pro45S, Pro28F

EMDN Z12149002

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number805750785P45SZ12149002CY Basic UDI-DIDate30 May 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Trade Name
pro 28F
Device Name
Pro45S
Pro28F
Model / Reference
Pro45S, PRO 28F, Pro28F
Primary DI / UDI-DI
08057507850517, 08057507850531, 08057507850524, 08057507851606
Basic UDI-DI
805750785P45SZ12149002CY, 805750785P28FZ12149002ZP
Direct Marketing DI
08057507850517
08057507850531
08057507850524
08057507851606
EMDN Code
Z12149002 Audiometric chambers
Device Class
Class I
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000047643

Other devices from Puma Srl

See all devices from Puma Srl →

Properties & raw data

Show properties, registry sources and raw records
Other properties (13)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (4)

  • EUDAMED 5851235a-3d23-4c7f-8218-2d84d418d9df 61 fields · synced 22 Oct 2026
  • EUDAMED 08057507850531|805750785P45SZ12149002CY 61 fields · synced 18 May 2026
  • EUDAMED 08057507850524|805750785P45SZ12149002CY 61 fields · synced 19 May 2026
  • EUDAMED 08057507851606|805750785P28FZ12149002ZP 61 fields · synced 14 Oct 2026