Identity
- Device Name
- Humidifier Bubble EUDAMED
- Model / Reference
- LB4010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977334881060 EUDAMED
- Basic UDI-DI
- 697733488Humidifier015K EUDAMED
- EMDN Code
- R060280 HUMIDIFICATION SYSTEMS - ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain 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: Tracheostomy tube speech valve
Humidifier Bubble by Ningbo Seasight Medical Instruments Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Tracheostomy tube speech valve.
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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 | 697733488Humidifier015K | Class I | Active |
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Manufacturer
- Manufacturer
- Ningbo Seasight Medical Instruments Co., Ltd.
- EUDAMED SRN
- CN-MF-000032275
- Authorised Representative
- Sungo Cert GmbH DE-AR-000010869
Sources (1)
- EUDAMED fa6fdc62-b14e-4aee-ba8a-5477b0ceb87a 61 fields · synced Jun 18, 2026