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clearflo F-100 - 100 Airwave Oscillometry Filters

by THORASYS Thoracic Medical Systems Inc.

Ref 101635

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number7540261tremofloC2N6 Basic UDI-DI 07540261016356UDI-DIDate20 May 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  • Withdrawn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
tremoflo
Model / Reference
101635
Primary DI / UDI-DI
07540261016356
Basic UDI-DI
7540261tremofloC2N6
EMDN Code
R0499 Respiratory filters - other
Device Class
Class IIa
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CA-MF-000039221
Authorised representative
OMC NI MEDICAL LIMITED XI-AR-000019483

Other devices from Thorasys Thoracic Medical Systems Inc

See all devices from Thorasys Thoracic Medical Systems Inc →

Properties

  • Measuring Function

Other properties (12)

  • 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
  • Incorporates Medicinal Product: No