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BiTrac

by Pulmodyne, Inc. 2 variants

Ref 10161575

BiTrac (10161575) is a Class IIa device made by Pulmodyne Inc., registered in EUDAMED on 3 Nov 2026 (Basic UDI-DI B-00841470105938), 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-00841470105938 Basic UDI-DI 00841470105938UDI-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  • Withdrawn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
Patient Circuit
Model / reference
10161575
Primary DI / UDI-DI
00841470105938
Basic UDI-DI
B-00841470105938
EMDN code
R020199 Breathing circuits and kits - other
Device class
Class IIa
EU registration type
Legacy device (under a directive)
EU market of registration
Lithuania

Manufacturer details

EUDAMED SRN
US-MF-000017334
Authorised representative
QNET B.V. NL-AR-000002695

Similar devices in this category

Other devices filed under BREATHING CIRCUITS AND KITS - OTHER.

Other devices from Pulmodyne Inc.

See all devices from Pulmodyne Inc. →

Properties

Other properties (12, all answered No)