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NephroCart

by Nephrocan Medi̇kal Sanayi̇ Ti̇caret Anoni̇m Şi̇rketi̇ 4 variants

Ref 4315310Model NephroCart550

NephroCart (4315310) is a Class IIb device made by Nephrocan Medi̇kal Sanayi̇ Ti̇caret Anoni̇m Şi̇rketi̇, registered in EUDAMED on 3 Nov 2026 (Basic UDI-DI B-868475920501PJ), active as of 7 Nov 2026.

Active European Union

CE MDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-868475920501PJ Basic UDI-DI D-868475920501PJUDI-DIDate3 Nov 2026RegisteredStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Active

Specification

EUDAMED

Device name
Sodium Bicarbonate Powder Containers
Model / reference
NephroCart550, 4315310
Primary DI / UDI-DI
D-868475920501PJ
Basic UDI-DI
B-868475920501PJ
EMDN code
F040201 Dialysis concentrates, basic solutions, powder
Device class
Class IIb
EU registration type
Legacy device (under a directive)
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000046244

Similar devices in this category

Other devices filed under DIALYSIS CONCENTRATES, BASIC SOLUTIONS, POWDER.

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Properties

Other properties (12, all answered No)