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Urea Broth

by BioMaxima Spółka Akcyjna 2 variants

Ref PS 593- 500, PW 3304, PW 3100, BT 5040.01, BT 5040.05, BT 5040.02, PS 593- 250

Urea Broth (PS 593- 500) is a Class A device made by BioMaxima Spółka Akcyjna, registered in EUDAMED on 7 Nov 2025 (Basic UDI-DI 59026439ASURBQD), active as of 24 Oct 2026.

Active European Union

CE IVDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number59026439ASURBQD Basic UDI-DI Date7 Nov 2025RegisteredStatusActive

Official records

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Specification

EUDAMED

Device name
Urea Broth Modified acc. to PN-A- 04023
Urea Broth Modified acc. to PN-A-04023
Model / reference
PS 593- 500, PW 3304, PW 3100, BT 5040.01, BT 5040.05, BT 5040.02, PS 593- 250
Primary DI / UDI-DI
05902643907690, 05902643941250, 05902643940789, 05902643951068, 05902643951075, 05902643950184, 05902643988194
Basic UDI-DI
59026439ASURBQD, 59026439ATURBRMYC, 59026439ABURBMLF
EMDN code
W0104010101, W0104010206, W0104010306
Device class
Class A
EU registration type
Standard device
EU market of registration
Poland

Manufacturer details

EUDAMED SRN
PL-MF-000039473

Similar devices in this category

Other devices filed under DEHYDRATED CULTURE MEDIA (DCM).

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Properties

  • Professional testing
Other properties (12, all answered No)