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Tube and Chamber Kit
EUDAMEDClass IIa (EU MDR)
Ref Hi-OT3Model Hi-OT1Ref Hi-OT2
Identity
- Trade Name
- Tube and Chamber Kit EUDAMED
- Device Name
- Tube and Chamber Kit EUDAMED
- Model / Reference
- Hi-OT1 EUDAMEDHi-OT3 EUDAMEDHi-OT2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16975984064571 EUDAMED16975984064564 EUDAMED
- Basic UDI-DI
- 6970341680112300GW EUDAMED
- Direct Marketing DI
- 16975984064571 EUDAMED16975984064564 EUDAMED
- EMDN Code
- R060280 HUMIDIFICATION SYSTEMS - ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Ireland 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
Tube and Chamber Kit by Shenzhen Lifotronic Technology Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 6970341680112300GW | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shenzhen Lifotronic Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000005654
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED 04f978d7-80ef-482f-b610-a5bf3f93ccc0 61 fields · synced Jul 26, 2026
- EUDAMED eef9b9e6-0ed5-4d7b-bfd2-bf154bf9f414 61 fields · synced May 18, 2026