FDA Registration
Active
🇲🇾 Malaysia
Iconic Blue Nitrile Glove- Tested for use with Chemotherapy Drugs and Fentanyl Citrate
Reg #: 3018240699
·
FEI: 3018240699
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
2
Classifications
4
Registration Details
- Registration Name
- ICONIC MEDICARE SDN. BHD.
- Registration Number
- 3018240699
- FEI Number
- 3018240699
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- PMT 798, Lingkaran Cassia Selatan, Taman Perindustrian Batu Kawan, 14110 Bandar Cassia, Penang, Malaysia.
- City
- Bandar Cassia Pulau Pinang
- Country
- MY
Regulatory Submissions
- 510(k) Number
- K222181
Owner / Operator
- Firm Name
- ICONIC MEDICARE SDN. BHD.
- Operator Number
- 10081175
- Address
- 1-2, Jalan Icon City, 14000 Bukit Mertajam, Pulau Pinang, Malaysia
- City
- Bukit Mertajam
- State
- Pulau Pinang
- Postal Code
- 14000
- Country
- MY
US Agent
- Business Name
- Integrated Assessment Services Pvt Ltd
- Contact Name
- Dennis Ralph Briscoe
- Address
- 149 E 200 N
- City
- Providence
- State
- UT
- ZIP
- 84332
- Country
- US
- [email protected]
- Phone
- 435 5123650
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Polymer Patient Examination Glove | LZA | Class 1 | General Hospital | No | 2023-01-23 |
| Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | OPJ | Class 1 | General Hospital | No | 2023-01-23 |
| Medical Glove, Specialty | LZC | Class 1 | General Hospital | No | 2023-01-23 |
| Fentanyl And Other Opioid Protection Glove | QDO | Class 1 | General Hospital | No | 2023-01-23 |
Proprietary Names
Iconic Blue Nitrile Glove- Tested for use with Chemotherapy Drugs and Fentanyl Citrate
Establishment Types
Manufacture Medical Device
Foreign Private Label Distributor