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Torquer

by Balton Sp. z o.o.

Ref TORQUER

Torquer is a Class I device made by Balton Sp. z o.o., registered in EUDAMED on 29 Jul 2026 (Basic UDI-DI B-05906868921752), active as of 25 Oct 2026.

Active European Union

CE MDR 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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberB-05906868921752 Basic UDI-DI Date29 Jul 2026RegisteredStatusActive
European UnionCE/MDD NumberB-05906868921752 Basic UDI-DI Date29 Jul 2026RegisteredStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR, CE/MDD Active

Specification

EUDAMED

Device name
Torquer
Model / reference
TORQUER
Primary DI / UDI-DI
05906868921752, 05906868954248, 05901297040364, 05901297181463
Basic UDI-DI
B-05906868921752, B-05906868954248, 5901297TORQUERF4, B-05901297181463
EMDN code
C0480 Cardiovascular guidewires - accessories
Device class
Class I
EU registration type
Legacy device (under a directive)
Standard device
EU market of registration
Poland

Manufacturer details

EUDAMED SRN
PL-MF-000010568

Similar devices in this category

Other devices filed under CARDIOVASCULAR GUIDEWIRES - ACCESSORIES.

Other devices from Balton Sp. z o.o.

See all devices from Balton Sp. z o.o. →

Properties

  • Supplied sterile
Other properties (13, all answered No)