Identity
- Trade Name
- Air Filter EUDAMEDBonhawa Air Filter FDA UDI
- Generic Name
- CPAP/BPAP unit ambient air filter, reusable FDA UDI
- Device Name
- Bonhawa Respiratory Humidifier EUDAMED
- Model / Reference
- RHF G3-2 EUDAMEDAF3 EUDAMEDAF FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860009312234 EUDAMEDFDA UDI
- Basic UDI-DI
- 08600093122A5X EUDAMED
- FDA Product Code
- BTT FDA UDI
- EMDN Code
- R040199 VENTILATION FILTERS - OTHER EUDAMED
- GMDN Term
- CPAP/BPAP unit ambient air filter, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5450 FDA UDI
- Market of Registration
- Spain EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Microbial medical gas filter, single-use
Air Filter by Telesair, Inc — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Microbial medical gas filter, single-use.
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- CARDINAL HEALTH — Cardinal Health 200, LLC · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 08600093122A5X | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Telesair, Inc
- EUDAMED SRN
- US-MF-000037957
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED 385608a5-a946-4dd7-a15d-0ee9ea9b5c68 61 fields · synced Jul 27, 2026
- FDA UDI d8caf852-97ff-487d-9672-361bc15c0fc8 32 fields · synced May 30, 2026