FDA Registration
Active
🇲🇾 Malaysia
JR ENGINEERING &MEDICAL TECHNOLOGIES (M) SDN BHD
Reg #: 3016785252
·
FEI: 3016785252
·
Expires 2026
Products
6
Proprietary Names
10
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- JR ENGINEERING &MEDICAL TECHNOLOGIES (M) SDN BHD
- Registration Number
- 3016785252
- FEI Number
- 3016785252
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- LOT 8 & 10 JLN ZURAH, LOT 1& 3, JLN ZURAH 1A/1,PUSAT PERINDUSTRIAN 2
- City
- RASA Selangor
- Country
- MY
Regulatory Submissions
- 510(k) Number
- K192328
Owner / Operator
- Firm Name
- JR ENGINEERING &MEDICAL TECHNOLOGIES (M) SDN BHD
- Operator Number
- 10065964
- Address
- LOT 8 & 10 JLN ZURAH, LOT 1& 3, JLN ZURAH 1A/1,PUSAT PERINDUSTRIAN 2
- City
- RASA
- State
- Selangor
- Postal Code
- 44200
- Country
- MY
US Agent
- Business Name
- Liberty Management Group Ltd.
- Contact Name
- Manoj Zacharias
- Address
- 75 Executive Drive,, Suite 114,
- City
- Aurora
- State
- IL
- ZIP
- 60504
- Country
- US
- [email protected]
- Phone
- 630 2702921
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Surgeon'S Gloves | KGO | Class 1 | General, Plastic Surgery | No | 2020-03-31 |
| Polymer Patient Examination Glove | LZA | Class 1 | General Hospital | No | 2020-03-31 |
| Latex Patient Examination Glove | LYY | Class 1 | General Hospital | No | 2020-03-31 |
| Medical Glove, Specialty | LZC | Class 1 | General Hospital | No | 2022-11-07 |
| Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | OPJ | Class 1 | General Hospital | No | 2022-01-19 |
| Fentanyl And Other Opioid Protection Glove | QDO | Class 1 | General Hospital | No | 2023-05-02 |
Proprietary Names
JR MEDIC
GUARDIAN
Black Nitrile Exam Powder Free Gloves
Blue Latex Exam Powder Free Gloves Chemo Rated
Jr Medic Blue Nitrile Examination Powder Free Gloves tested for use with chemotherapy drugs
Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs
Nitrile Surgical Powder Free Gloves
Orange /Purple Exam Nitrile Powder Free Gloves
Latex Examination Powder-free Gloves
Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs and Fentanyl Citrate
Establishment Types
Manufacture Medical Device