Sleep Apnea Ventilator

by Nanjing Superstar Medical Equipment Co., Ltd. 5 variants

Ref S9525Model S9130

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

Region	Authorization	Number	Date	Status
European Union	CE/MDR	Number697421341S913096 Basic UDI-DI 06974213416580UDI-DI	Date9 Apr 2026Registered	StatusActive

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

Active
Expiring
Withdrawn
Listed
Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name: Sleep Apnea Ventilator
Model / Reference: S9130, S9525

Primary DI / UDI-DI: 06974213416580
Basic UDI-DI: 697421341S913096
Direct Marketing DI: 06974213416580
EMDN Code: Z12030104 Portable pulmonary ventilators

Device Class: Class IIa
EU market of registration: Spain

Manufacturer details

EUDAMED SRN: CN-MF-000020034
Authorised representative: Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

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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