Is this your brand? Sign in to claim ownership.
Sign in to claim this brandWhat Bmc Medical., Ltd. makes
Bmc Medical produces reusable nasal and full-face masks for CPAP and BPAP therapy, including nasal pillow and full-coverage designs, as well as home-use CPAP and BPAP devices. Their portfolio also includes heated and non-heated respiratory humidifiers, ventilator breathing circuits, and associated accessories like carrying cases, power cords, and software for ventilator applications.
The company’s devices are classified under FDA regulations as Class I and Class II, with many authorised through the 510(k) and UDI processes. These products are listed under US regulatory frameworks and are intended for use in respiratory support and sleep therapy applications.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- —
Catalogue (170)
Page 4 of 4| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Luna® G3 BPAP 25A | LG3700 | FDA UDI | Class II | Active |
| Filter Cap | FC-E1 | FDA UDI | Class II | Active |
| Luna II QX Auto CPAP | LQX2A00 | FDA UDI | Class II | Active |
| Siesta 2 Full Face Mask | F5A+(Small) | FDA UDI | Class II | Active |
| Siesta Nasal Mask (XL) | N5B (Extra Large) | FDA UDI | Class II | Active |
| Rio™ II Nasal Pillow Interface Replacement Headgear | NA | FDA UDI | Class II | Active |
| Luna® G3 APAP | LG3600 | FDA UDI | Class II | Active |
| Numa II Full Face Mask (S) | F4(Small) | FDA UDI | Class II | Active |
| Luna® II CPAP | LG2000 | FDA UDI | Class II | Active |
| RESmart® CPAP System with Integrated Heated Humidifier | RESmart (BMC-50) | FDA UDI | Class II | Active |
| Luna® G3 BPAP System | LG3800-25VT | FDA UDI | Class II | Active |
| G3 X BPAP System | G4800 | FDA UDI | Class II | Active |
| Siesta Nasal Mask (M) | N5B (Medium) | FDA UDI | Class II | Active |
| Siesta Nasal Mask (S) | N5B (Small) | FDA UDI | Class II | Active |
| Siesta Full Face Mask (M) | F5A (Medium) | FDA UDI | Class II | Active |
| Luna® G3 BPAP System | LG3800-25VT | FDA UDI | Class II | Active |
| Rio II Nasal Pillows Interface Replacement Nasal Pillows-S | P2(Small) | FDA UDI | Class II | Active |
| Luna® Auto CPAP System | E-20AJ-H-O | FDA UDI | Class II | Active |
| Luna® G3 APAP | LG3600 | FDA UDI | Class II | Active |
| Viva Nasal Mask (Model: NM4), Numa Full Face Mask (Model: BMC-FM2) | K163464 | FDA 510(k) | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.