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Hygie® ProHy21® Vomit ProKit
EUDAMEDClass I (EU MDR)
Ref KT-PRO-HY21-V01Model Hygie Kits
Identity
- Trade Name
- Hygie® ProHy21® Vomit ProKit EUDAMED
- Model / Reference
- Hygie Kits EUDAMEDKT-PRO-HY21-V01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07540233002394 EUDAMED
- Basic UDI-DI
- 7540233HYKEE 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
Category: General-purpose suction system, pneumatic
Hygie® ProHy21® Vomit ProKit by Hygie Canada Inc — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as General-purpose suction system, pneumatic.
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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 | 7540233HYKEE | 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 437e725f-9b43-4bb6-89b0-e97f2c45133c 61 fields · synced Oct 8, 2026