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Sodium Bicarbonate Bag

by Allmed Middle East 4 variants

Ref BIOCARD S 650 g BIOCARD S 900 gModel BIOCARD 650 g, BIOCARD 900 g, BIOCARD S 650 g and BIOCARD S 900 g

Active European Union

CE MDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number6221166BIOCARDK6 Basic UDI-DI 06221166009346UDI-DIDate10 Jun 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Sodium Bicarbonate Bag
Model / Reference
BIOCARD 650 g, BIOCARD 900 g, BIOCARD S 650 g and BIOCARD S 900 g, BIOCARD S 650 g BIOCARD S 900 g
Primary DI / UDI-DI
06221166009346
Basic UDI-DI
6221166BIOCARDK6
Direct Marketing DI
06221166009346
EMDN Code
F040201 Dialysis concentrates, basic solutions, powder
Device Class
Class IIb
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
EG-MF-000025747
Authorised representative
Allmed Medical GmbH DE-AR-000007830

Other devices from Allmed Middle East

See all devices from Allmed Middle East →

Properties

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