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Hygie® Isolation Kit / Hy-SO®
EUDAMEDClass I (EU MDR)
Ref HY-HYSO-000-006 Model Hygie Kits
Identity
- Trade Name
- Hygie® Isolation Kit / Hy-SO® EUDAMED
- Model / Reference
- Hygie Kits EUDAMEDHY-HYSO-000-006 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07540233002233 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® Isolation Kit / Hy-SO® 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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- VarioAir B BS — Drägerwerk AG & Co. KGaA · Class IIa
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 6a433aff-2a89-46ea-a307-26bce56b3bf9 61 fields · synced Jul 17, 2026