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Hygie® Hygienic Cover® Bedpan / Commode Liner

EUDAMED

Class I (EU MDR)

Ref SA-HYGI-CLBI-000

by Hygie Canada Inc

Identity

Trade Name
Hygie® Hygienic Cover® Bedpan / Commode Liner EUDAMED
Device Name
Body Fluid Management Solutions Family EUDAMED
Model / Reference
SA-HYGI-CLBI-000 EUDAMED

Identifiers

Primary DI / UDI-DI
07540233000994 EUDAMED
Basic UDI-DI
7540233BFMBT EUDAMED
EMDN Code
A060399 FLUID COLLECTION BAGS AND SYSTEMS - OTHER EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
France 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

Hygie® Hygienic Cover® Bedpan / Commode Liner by Hygie Canada Inc — 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

Manufacturer
Hygie Canada Inc
EUDAMED SRN
CA-MF-000027143
Authorised Representative
Emergo Europe B.V. NL-AR-000000116

Sources (1)

  • EUDAMED 967af990-f83e-4a46-bf56-c3a4390c6929 61 fields · synced Oct 6, 2026