FDA Registration
Active
🇲🇾 Malaysia
HAMAGAWA INDUSTRIAL (M) SDN BHD
Reg #: 3008840738
·
FEI: 3008840738
·
Expires 2026
Products
1
Proprietary Names
75
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- HAMAGAWA INDUSTRIAL (M) SDN BHD
- Registration Number
- 3008840738
- FEI Number
- 3008840738
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Lot 26, Jalan 8, Bakar Arang Industrial Estate
- City
- Sungai Petani Kedah
- Country
- MY
Owner / Operator
- Firm Name
- HAMAGAWA INDUSTRIAL (M) SDN BHD
- Operator Number
- 10047158
- Address
- Lot 26, Jalan 8, Bakar Arang Industrial Estate
- City
- Sungai Petani
- State
- Kedah
- Postal Code
- 08000
- Country
- MY
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2014-07-08 |
Proprietary Names
Trial Liner, 10, 36mm Head, Size 60 62mm
Screw Inserter
Trial Femoral Head, 28mm, S
Kratos Trial Neck, H/O (Lateralized)
Trial Femoral Head, 36mm, XL
Trial Acetabular Cup, Size 52mm
Straight Cup Inserter
Quick Release Box Osteotome
Trial Acetabular Cup, Size 60mm
Large Reamer Handle
Trial Acetabular Cup, Size 56mm
Tray, Bonded Stem
Trial Liner, Neutral, 36mm Head, Size 52 54mm
Trial Acetabular Cup, Size 68mm
Trial Femoral Head, 32mm, L
Screw Driver Handle
Trial Femoral Head, 36mm, M
Trial Liner, 10, 28mm Head, Size 52 54mm
Broach Handle power adapter
Trial Femoral Head, 32mm, S
Trial Femoral Head, 36mm, S
Trial Liner, 10, 36mm Head, Size 56 58mm
Calcar Reamer, Large
Trial Liner, Neutral, 36mm Head, Size 60 68mm
Drill Depth Gauge
Stem Impactor
Trial Liner, Neutral, 28mm Head, Size 44 46mm
Straight Broach Handle
Alignment Guide
Trial Acetabular Cup, Size 54mm
Trial Acetabular Cup, Size 64mm
Trial Femoral Head, 28mm, L
Tapered Pin Reamer
Trial Femoral Head, 32mm, M
Trial Acetabular Cup, Size 62mm
Quick Release Head Impactor
Trial Acetabular Cup, Size 48mm
Trial Liner, Neutral, 32mm Head, Size 48 50mm
Trial Liner, 10, 32mm Head, Size 52 54mm
Trial Liner, Neutral, 32mm Head, Size 52 54mm
Trial Acetabular Cup, Size 44mm
Stem Positioner
Trial Liner, 10, 32mm Head, Size 60 68mm
Osteotomy Guide
Trial Liner, 10, 36mm Head, Size 52 54mm
Trial Acetabular Cup, Size 50mm
Trial Femoral Head, 36mm, L
IM Drill
Trial Liner, 10, 28mm Head, Size 44 46mm
Trial Femoral Head, 32mm, XL
Drill Guide
Liner Impactor, 28mm
Trial Femoral Head, 28mm, M
Trial Liner, Neutral, 36mm Head, Size 56 58mm
Reamer Shaft
Trial Acetabular Cup, Size 58mm
Trial Liner, 10, 28mm Head, Size 48 50mm
Tray, Tryon Acetabular System
Liner Impactor, 32mm
Quick Connect Drill Shaft
Kratos Trial Neck, Standard
Trial Liner, 10, 32mm Head, Size 48 50mm
Trial Liner, Neutral, 28mm Head, Size 48 50mm
Trial Liner, 10, 32mm Head, Size 56 58mm
3.5 Hex Screw Driver Shaft
Trial Acetabular Cup, Size 66mm
Trial Liner, Neutral, 32mm Head, Size 60 68mm
Trial Liner, Neutral, 28mm Head, Size 52 54mm
Quick Release Stem Impactor
Liner Impactor, 36mm
Tryon 2 Tray
Stepped Entry Reamer
Trial Liner, Neutral, 32mm Head, Size 56 58mm
Trial Acetabular Cup, Size 46mm
Dymaxeon Spine System
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)