FDA Registration
Active
🇲🇾 Malaysia
WRP ASIA PACIFIC SDN. BHD.
Reg #: 8041005
·
FEI: 3002808507
·
Expires 2026
Products
12
Proprietary Names
1
Establishment Types
3
Classifications
12
Registration Details
- Registration Name
- WRP ASIA PACIFIC SDN. BHD.
- Registration Number
- 8041005
- FEI Number
- 3002808507
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- LOT 1, JALAN 3, KAWASAN PERUSAHAAN BANDAR BARU
- City
- SALAK TINGGI, SEPANG Selangor
- Country
- MY
Regulatory Submissions
- 510(k) Number
- K012135
Owner / Operator
- Firm Name
- WRP ASIA PACIFIC SDN. BHD.
- Operator Number
- 8041005
- Address
- LOT 1, JALAN 3, KAWASAN PERUSAHAAN BANDAR BARU SALAK TINGGI
- City
- SEPANG
- State
- Selangor
- Postal Code
- 43900
- Country
- MY
- Correspondent
- Saravanan - Ramasamy
US Agent
- Business Name
- SG Global, LLC
- Contact Name
- Michael Scaglione
- Address
- 8465 W Wadora Cir Nw
- City
- North Canton
- State
- OH
- ZIP
- 44720
- Country
- US
- [email protected]
- Phone
- 330 2840252
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Surgeon'S Gloves | KGO | Class 1 | General, Plastic Surgery | No | 2008-01-22 |
| Latex Patient Examination Glove | LYY | Class 1 | General Hospital | No | 2008-01-22 |
| Medical Glove, Specialty | LZC | Class 1 | General Hospital | No | 2009-08-13 |
| Polymer Patient Examination Glove | LZA | Class 1 | General Hospital | No | 2008-01-22 |
| Catheter, Irrigation | GBX | Class 1 | General, Plastic Surgery | No | 1994-08-23 |
| Patient Examination Glove | FMC | Class 1 | General Hospital | No | 2008-04-17 |
| Catheter, Retention Type, Balloon | EZL | Class 2 | Gastroenterology, Urology | No | 2008-01-22 |
| Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | OPJ | Class 1 | General Hospital | No | 2023-09-03 |
| Fentanyl And Other Opioid Protection Glove | QDO | Class 1 | General Hospital | No | 2023-09-03 |
| Tube, Tracheal (W/Wo Connector) | BTR | Class 2 | Anesthesiology | No | 2008-04-17 |
| Catheter, Balloon Type | GBA | Class 1 | General, Plastic Surgery | No | 1989-03-15 |
| Radiographic Protective Glove | IWP | Class 1 | Radiology | No | 1999-10-21 |
Proprietary Names
IRONTON DISPOSABLE PF NTR GLOVES
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198