FDA Registration
Active
🇸🇬 Singapore
ResMed Asia Pte. Ltd.
Reg #: 3017684630
·
FEI: 3017684630
·
Expires 2026
Products
7
Proprietary Names
3
Establishment Types
2
Classifications
7
Registration Details
- Registration Name
- ResMed Asia Pte. Ltd.
- Registration Number
- 3017684630
- FEI Number
- 3017684630
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 3 Tuas Avenue 2
- City
- Singapore South West
- Country
- SG
Regulatory Submissions
- 510(k) Number
- K220028
Owner / Operator
- Firm Name
- RESMED CORP.
- Operator Number
- 9002319
- Address
- 9001 Spectrum Center Blvd, --
- City
- San Diego
- State
- CA
- Postal Code
- 92123
- Country
- US
- Correspondent
- David Lanfranchi
US Agent
- Business Name
- ResMed Corp
- Contact Name
- David Lanfranchi
- Address
- 9001 Spectrum Center Blvd
- City
- San Diego
- State
- CA
- ZIP
- 92123
- Country
- US
- [email protected]
- Phone
- 858 8365000
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Ventilator, Non-Continuous (Respirator) | BZD | Class 2 | Anesthesiology | No | 2018-07-11 |
| Ventilator, Continuous, Non-Life-Supporting | MNS | Class 2 | Anesthesiology | No | 2023-02-22 |
| Tubing, Pressure And Accessories | BYX | Class 1 | Anesthesiology | No | 2007-01-25 |
| Mask, Oxygen | BYG | Class 1 | Anesthesiology | No | 2004-06-18 |
| Ventilatory Effort Recorder | MNR | Class 2 | Anesthesiology | No | 2022-03-23 |
| Generator, Oxygen, Portable | CAW | Class 2 | Anesthesiology | No | 2016-11-14 |
| Set, Tubing And Support, Ventilator (W Harness) | BZO | Class 1 | Anesthesiology | No | 2023-06-01 |
Proprietary Names
Nightowl
AirFit F20
F20 QuietAir Elbow
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device