Identity
- Trade Name
- Bonhawa EUDAMED
- Device Name
- Bonhawa Respiratory Humidifier EUDAMED
- Model / Reference
- RHF G3-2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00860009312210 EUDAMED
- Basic UDI-DI
- 08600093122A5X EUDAMED
- Direct Marketing DI
- 00860009312210 EUDAMED
- EMDN Code
- R060202 OXYGEN ADMINISTRATION HUMIDIFICATION SYSTEMS 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
Bonhawa by Telesair, Inc — 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 | 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 f508a9b6-6e80-4570-9094-0f446a8d6688 61 fields · synced May 23, 2026