Identity
- Trade Name
- Water Chamber Adapter EUDAMED
- Device Name
- Bonhawa Respiratory Humidifier EUDAMED
- Model / Reference
- RHF G3-2 EUDAMEDWCA01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00860009312227 EUDAMED
- Basic UDI-DI
- 08600093122A5X EUDAMED
- Unit of Use DI
- 10860009312224 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
Yes
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Tracheostomy tube speech valve
Water Chamber Adapter by Telesair, Inc — 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 | 08600093122A5X | Class IIa | Active |
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Manufacturer
- Manufacturer
- Telesair, Inc
- EUDAMED SRN
- US-MF-000037957
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED 338ad459-d5ae-4aa5-b578-5a74a1b055a8 61 fields · synced Jul 9, 2026