FDA Registration
Active
🇲🇾 Malaysia
KAREX INDUSTRIES SDN BHD
Reg #: 9680135
·
FEI: 1000535235
·
Expires 2026
Products
5
Proprietary Names
1
Establishment Types
3
Classifications
5
Registration Details
- Registration Name
- KAREX INDUSTRIES SDN BHD
- Registration Number
- 9680135
- FEI Number
- 1000535235
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- PTD. 7906/7907, TAMAN PONTIAN JAYA, BT. 34, JALAN JOHOR
- City
- PONTIAN Johor
- Country
- MY
Regulatory Submissions
- 510(k) Number
- K141059
Owner / Operator
- Firm Name
- KAREX INDUSTRIES SDN BHD
- Operator Number
- 9007040
- Address
- PTD. 7906/7907, Taman Pontian Jaya, BT. 34, Jalan Johor
- City
- Pontian
- State
- Johor
- Postal Code
- 82000
- Country
- MY
- Correspondent
- Leng Kian - Goh
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Condom | HIS | Class 2 | Obstetrics/Gynecology | No | 2024-03-21 |
| Condom, Synthetic | MOL | Class 2 | Obstetrics/Gynecology | No | 2025-05-08 |
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2025-04-08 |
| Lubricant, Personal | NUC | Class 2 | Obstetrics/Gynecology | No | 2016-03-09 |
| Barrier, Std, Oral Sex | MSC | Class 2 | Obstetrics/Gynecology | No | 2017-10-27 |
Proprietary Names
Carex Hybrid Personal Lubricant
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device
Repack or Relabel Medical Device