Identity
- Trade Name
- Ultrasonic nebulizer EUDAMED
- Device Name
- Ultrasonic nebulizer EUDAMED
- Model / Reference
- VP-U2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970979571495 EUDAMED
- Basic UDI-DI
- 697097957VP-UWQ EUDAMED
- Direct Marketing DI
- 06970979571495 EUDAMED
- EMDN Code
- R060101 COLD NEBULISATION SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
Yes
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Ultrasonic nebulizer by Vapo Healthcare Co., 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 | 697097957VP-UWQ | Class IIa | Active |
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Manufacturer
- Manufacturer
- Vapo Healthcare Co., Ltd.
- EUDAMED SRN
- CN-MF-000014728
- Authorised Representative
- Share info GmbH DE-AR-000005132
Sources (1)
- EUDAMED 9dcad08e-2420-410a-b3e5-8fbe1a803d13 61 fields · synced Jul 14, 2026