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U901V

by B Medical Systems S.à r.l.

Ref 991.8690.**

Active European Union

CE MDR

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

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 Number05450104511110A5 Basic UDI-DI 05450104571213UDI-DIDate31 Oct 2022RegisteredStatusActive

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  • Withdrawn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
Ultralow freezers
Model / reference
991.8690.**
Primary DI / UDI-DI
05450104571213
Basic UDI-DI
05450104511110A5
EMDN code
Z121702 Blood and blood components freezers
Device class
Class IIa
System or procedure pack
System which is a device in itself
EU registration type
Standard device
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
LU-MF-000000128

Other devices from B Medical Systems S.à r.l.

See all devices from B Medical Systems S.à r.l. →

Properties

Other properties (14)

  • Supplied sterile: No
  • Sterilise before use: No
  • Implantable: No
  • Reusable: No
  • Contains latex: No
  • Reprocessed single-use device: No
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No
  • Incorporates a substance derived from human blood or plasma: No
  • Contains human tissues or cells: No
  • Contains animal tissues or cells: No
  • Contains endocrine-disrupting substances: No
  • Administering medicine: No
  • Measuring function: No
  • Incorporates a medicinal substance: No