Identity
- Trade Name
- HY21 Bottomless Bedpan Seat EUDAMED
- Device Name
- Body Fluid Management Solutions Family EUDAMED
- Model / Reference
- AC-SIEG-HY21-SFO EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07540233002585 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
HY21 Bottomless Bedpan Seat 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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 7540233BFMBT | Class I | Active |
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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 50ad4a4d-676b-4324-9e14-9cab44fb779a 61 fields · synced Jul 13, 2026