FDA Registration
Active
🇲🇾 Malaysia
ResMed Malaysia Operations Sdn Bhd
Reg #: 3038236812
·
FEI: 3038236812
·
Expires 2026
Products
5
Proprietary Names
2
Establishment Types
1
Classifications
5
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Registration Details
- Registration Name
- ResMed Malaysia Operations Sdn Bhd
- Registration Number
- 3038236812
- FEI Number
- 3038236812
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No 80&81, Jalan I-Park SAC 5, Taman Perindustrian I-Park
- City
- Senai Johor
- Country
- MY
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 | 2011-07-26 |
| Mask, Oxygen | BYG | Class 1 | Anesthesiology | No | 2004-06-18 |
| Ventilatory Effort Recorder | MNR | Class 2 | Anesthesiology | No | 2016-12-15 |
| Mask, Gas, Anesthetic | BSJ | Class 1 | Anesthesiology | No | 2011-09-20 |
| Set, Tubing And Support, Ventilator (W Harness) | BZO | Class 1 | Anesthesiology | No | 2023-06-01 |
Proprietary Names
AirFit F20
F20 QuietAir Elbow
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)