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Respiratory Muscle Trainer

by Chongqing Sonmol Technology Co., Ltd.

Ref MFBT-05Model MFBT-01, MFBT-02, MFBT-03, MFBT-04, MFBT-05, MFBT-06、, MFBT-07、, MFBT-08

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, self-declared

Class I: no certifier involved

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 Number697503805RMTTU Basic UDI-DI 06975038050577UDI-DIDate4 Jun 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Respiratory Muscle Trainer
Model / Reference
MFBT-01, MFBT-02, MFBT-03, MFBT-04, MFBT-05, MFBT-06、, MFBT-07、, MFBT-08
Primary DI / UDI-DI
06975038050577
Basic UDI-DI
697503805RMTTU
EMDN Code
R020199 Breathing circuits and kits - other
Device Class
Class I
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000010534
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Chongqing Sonmol Technology Co., Ltd.

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