Identity
- Device Name
- Hydra-Neb Nebulizer EUDAMED
- Model / Reference
- MY-138 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060461080589 EUDAMED
- Basic UDI-DI
- 50604610825007G8 EUDAMED
- EMDN Code
- Z12040210 ULTRASONIC NEBULISERS EUDAMED
Classification
- Device Class
- Class IIa 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
Hydra-Neb Nebulizer by Venture Health Ltd — Class IIa — 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 | 50604610825007G8 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Venture Health Ltd
- EUDAMED SRN
- UK-MF-000047587
- Authorised Representative
- Global E-commerce Experts Europe BV NL-AR-000038301
Sources (1)
- EUDAMED 235aa1a3-41ad-465c-ad47-62fa21967619 61 fields · synced Jun 18, 2026