FDA Registration
Inactive
🇲🇾 Malaysia
BROSMED MEDICAL (MALAYSIA) SDN. BHD.
·
Expires 2026
Products
3
Proprietary Names
14
Establishment Types
1
Classifications
3
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Registration Details
- Registration Name
- BROSMED MEDICAL (MALAYSIA) SDN. BHD.
- Status
- Inactive
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- NO.2466, Lorong IKS Bukit Minyak 1E, Taman IKS Bukit Minyak
- City
- Simpang Ampat Pulau Pinang
- Country
- MY
Owner / Operator
- Firm Name
- BROSMED MEDICAL (MALAYSIA) SDN. BHD.
- Operator Number
- 10096042
- Address
- NO.2466, Lorong IKS Bukit Minyak 1E, Taman IKS Bukit Minyak
- City
- Simpang Ampat
- State
- Pulau Pinang
- Postal Code
- 14100
- Country
- MY
- Correspondent
- Crystal Lee
US Agent
- Business Name
- Registrar Corp
- Contact Name
- David Lennarz
- Address
- 144 Research Drive
- City
- Hampton
- State
- VA
- ZIP
- 23666
- Country
- US
- [email protected]
- Phone
- 757 2240177
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheter, Angioplasty, Peripheral, Transluminal | LIT | Class 2 | Cardiovascular | No | 2026-06-11 |
| Catheters, Transluminal Coronary Angioplasty, Percutaneous | LOX | Class 2 | Cardiovascular | No | 2026-06-11 |
| Catheter, Percutaneous, Cutting/Scoring | PNO | Class 2 | Cardiovascular | No | 2026-06-11 |
Proprietary Names
Parafleet SC 035 PTA Balloon Dilatation Catheter
Parafleet SC 018 PTA Balloon Dilatation Catheter
Parafleet SC 014 PTA Balloon Dilatation Catheter
Castor, Achilles, and Hermes NC PTA Balloon Dilatation Catheters
Tiche PTA Balloon Dilatation Catheter
POT PTCA Balloon Dilatation Catheter
Polux , Minerva and Atropos PTA Balloon Dilatation Catheter
Apollo Balloon Dilatation Catheter
Aperi NC Balloon Dilatation Catheter
Artimes Pro Balloon Dilatation Catheter
Aperi SC Balloon Dilatation Catheter
Aperi NC Balloon Dilatation Cathter
Tri-Wedge PTA Scoring Balloon Dilatation Catheter
Artimes Balloon Dilatation Catheter
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)