POWERbreathe Plus Inspiratory Muscle Trainer

by POWERbreathe International Limited 9 variants

Ref PB2006

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR	Number5060127400002NL Basic UDI-DI 05060127407996UDI-DI	Date7 May 2025Registered	StatusActive

Certificates

0 certificates · EUDAMED

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

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name: POWERbreathe Plus Inspiratory Muscle Trainer
Model / Reference: PB2006

Primary DI / UDI-DI: 05060127407996
Basic UDI-DI: 5060127400002NL
EMDN Code: R9099 Respiratory and anaesthesia devices - other

Device Class: Class I
EU market of registration: Germany

Manufacturer details

EUDAMED SRN: UK-MF-000045438
Authorised representative: HaB GmbH DE-AR-000041460

From the manufacturer

Manufacturer's product page: POWERbreathe Plus Inspiratory Muscle Trainer

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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