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Breathing Trainer

EUDAMED

Class I (EU MDR)

Ref LY-BT03Model LY-BT01Ref LY-BT02Ref LY-BT04/99602

by Linye Health Tech(ningbo)co., Ltd

Identity

Trade Name
BREATHING TRAINER EUDAMED
Device Name
BREATHING TRAINER EUDAMED
Model / Reference
LY-BT01 EUDAMED
LY-BT03 EUDAMED
LY-BT02 EUDAMED
LY-BT04/99602 EUDAMED

Identifiers

Primary DI / UDI-DI
06975394401426 EUDAMED
06975394401372 EUDAMED
06975394401433 EUDAMED
Basic UDI-DI
697539440LYBT00VQ EUDAMED
EMDN Code
R900902 INSPIRATORY AND EXPIRATORY FLOW STIMULATORS/RESPIRATORY MUSCLES TRAINERS EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Germany EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Breathing Trainer by Linye Health Tech(ningbo)co., Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

EUDAMED SRN
CN-MF-000024232
Authorised Representative
Sungo Cert GmbH DE-AR-000010869

Sources (3)

  • EUDAMED d70e3929-395c-400f-818b-fc5e1af7be3f 61 fields · synced Oct 6, 2026
  • EUDAMED cccf4e0c-77e1-4ddf-ad9b-53b25ee99ad7 61 fields · synced May 18, 2026
  • EUDAMED f4f6e1a6-4973-4cc0-9c45-a9f7565a0a27 61 fields · synced May 18, 2026