FDA Registration
Active
🇲🇾 Malaysia
CENTRAL MEDICARE SDN BHD
Reg #: 3008253024
·
FEI: 3008253024
·
Expires 2026
Products
6
Proprietary Names
5
Establishment Types
2
Classifications
6
Registration Details
- Registration Name
- CENTRAL MEDICARE SDN BHD
- Registration Number
- 3008253024
- FEI Number
- 3008253024
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Plot 2609-2620, Batu 8, Jalan Changkat Jong
- City
- Teluk Intan Perak
- Country
- MY
Regulatory Submissions
- 510(k) Number
- K173942
Owner / Operator
- Firm Name
- Central Medicare Sdn Bhd
- Operator Number
- 10028684
- Address
- Plot 2609-2620, Batu 8, Jalan Changkat Jong,
- City
- Teluk Intan
- State
- Perak
- Postal Code
- 36000
- Country
- MY
- Correspondent
- Muhammad Abdul Rahman
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 |
|---|---|---|---|---|---|
| Polymer Patient Examination Glove | LZA | Class 1 | General Hospital | No | 2018-11-16 |
| Medical Glove, Specialty | LZC | Class 1 | General Hospital | No | 2018-03-06 |
| Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | OPJ | Class 1 | General Hospital | No | 2024-08-02 |
| Fentanyl And Other Opioid Protection Glove | QDO | Class 1 | General Hospital | No | 2024-08-02 |
| Latex Patient Examination Glove | LYY | Class 1 | General Hospital | No | 2023-08-21 |
| Surgeon'S Gloves | KGO | Class 1 | General, Plastic Surgery | No | 2023-08-21 |
Proprietary Names
HALYARD* Purple Nitrile* Powder Free Exam Textured 9.5? Glove
Non Sterile Powder Free Polyurethane Examination Gloves (Blue and Black Colors)
Lavender Exam Gloves
Purple Nitrile Exam Glove
Orange Non Sterile Powder Free Nitrile Examination Gloves
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device