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Hygie® Hygienic Cover® Vomit bag
EUDAMEDClass I (EU MDR)
Ref 1-EVM12Ref SA-HYGI-VOM0-000Ref SA-HYGI-VOM0-N00
Identity
- Trade Name
- Hygie® Hygienic Cover® Vomit bag EUDAMED
- Device Name
- Body Fluid Management Solutions Family EUDAMED
- Model / Reference
- 1-EVM12 EUDAMEDSA-HYGI-VOM0-000 EUDAMEDSA-HYGI-VOM0-N00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07540233002011 EUDAMED07540233001472 EUDAMED07540233001502 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® Vomit bag 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 (3)
- EUDAMED cfa63f5f-4409-4c47-b2b5-38579527fdc9 61 fields · synced Jul 27, 2026
- EUDAMED c00b13ed-9f81-4e3c-86db-35f54e4f1353 61 fields · synced May 18, 2026
- EUDAMED eea03c32-41ce-45dc-98c0-82c63a92692a 61 fields · synced May 18, 2026