Silicone Reservoir

by Hangzhou Fushan Medical Appliances Co., Ltd. 7 variants

Ref SR400S

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	Number69536763SR001UL Basic UDI-DI 06953676304252UDI-DI	Date29 Sep 2025Registered	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Withdrawn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

Model / Reference: SR400S

Primary DI / UDI-DI: 06953676304252
Basic UDI-DI: 69536763SR001UL
EMDN Code: A060301 Collection bags and other containers for drainages and fistulas, single use

Device Class: Class I
EU market of registration: Netherlands

Manufacturer details

EUDAMED SRN: CN-MF-000022768
Authorised representative: SUNGO Europe B.V. NL-AR-000000247

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See all devices from Hangzhou Fushan Medical Appliances Co., Ltd. →

Properties

Sterile

Other properties (12)

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