FDA Registration
Active
🇲🇾 Malaysia
MADEWELL MEDICAL TECHNOLOGY (MALAYSIA) SDN., BHD.
Reg #: 3038139564
·
FEI: 3038139564
·
Expires 2026
Products
7
Proprietary Names
3
Establishment Types
2
Classifications
7
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Registration Details
- Registration Name
- MADEWELL MEDICAL TECHNOLOGY (MALAYSIA) SDN., BHD.
- Registration Number
- 3038139564
- FEI Number
- 3038139564
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Lot 202, Kawasan Perindustrian Kuala Ketil,
- City
- Kuala Ketil Kedah
- Country
- MY
Owner / Operator
- Firm Name
- Madewell Medical Technology (Malaysia) Sdn., Bhd.
- Operator Number
- 10092929
- Address
- Lot 202, Kawasan Perindustrian Kuala Ketil,
- City
- Kuala Ketil
- State
- Kedah
- Postal Code
- 9300
- Country
- MY
- Correspondent
- Xu YaLin
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Tubing, Pressure And Accessories | BYX | Class 1 | Anesthesiology | No | 2025-03-07 |
| Cannula, Nasal, Oxygen | CAT | Class 1 | Anesthesiology | No | 2025-03-07 |
| Collector, Urine, Powered, Non Indwelling Catheter | NZU | Class 1 | Gastroenterology, Urology | No | 2025-03-07 |
| Catheter, Straight | EZD | Class 2 | Gastroenterology, Urology | No | 2025-03-07 |
| Catheter, Retention Type, Balloon | EZL | Class 2 | Gastroenterology, Urology | No | 2025-03-07 |
| Catheters, Suction, Tracheobronchial | BSY | Class 1 | Anesthesiology | No | 2025-03-07 |
| Airway, Nasopharyngeal | BTQ | Class 1 | Anesthesiology | No | 2026-03-26 |
Proprietary Names
MADEWELL
QiVi Acute MEC
MEDLINE
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)