Hygie® Hygienic Cover® Urinal Bag

by Hygie Canada Inc 3 variants

Ref SA-HYGI-URI0-N00

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	Number7540233BFMBT Basic UDI-DI 07540233001410UDI-DI	Date13 Apr 2026Registered	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Withdrawn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: Body Fluid Management Solutions Family
Model / Reference: SA-HYGI-URI0-N00

Primary DI / UDI-DI: 07540233001410
Basic UDI-DI: 7540233BFMBT
EMDN Code: A060399 Fluid collection bags and systems - other

Device Class: Class I
EU market of registration: France

Manufacturer details

EUDAMED SRN: CA-MF-000027143
Authorised representative: Emergo Europe B.V. NL-AR-000000116

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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