FDA Registration
Active
🇲🇾 Malaysia
Biogel PI UltraTouch S Surgical Glove
Reg #: 3025355668
·
FEI: 3025355668
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Molnlycke Health Care SDN BHD
- Registration Number
- 3025355668
- FEI Number
- 3025355668
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Lot 12A, Jalan Hi-Tech 7, Industrial Zone Phase 2, Kulim Hi-Tech Park
- City
- Kulim Kedah
- Country
- MY
Regulatory Submissions
- 510(k) Number
- K190077
Owner / Operator
- Firm Name
- MOLNLYCKE HEALTH CARE US LLC
- Operator Number
- 8030877
- Address
- 5445 Triangle Parkway, Suite 400
- City
- Peachtree Corners
- State
- GA
- Postal Code
- 30092
- Country
- US
- Correspondent
- Megan Bevill
US Agent
- Business Name
- MOLNLYCKE HEALTH CARE US LLC
- Contact Name
- Megan Bevill
- Address
- 5445 Triangle Parkway, Suite 400
- City
- Peachtree Corners
- State
- GA
- ZIP
- 30092
- Country
- US
- [email protected]
- Phone
- 770 5479196
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Surgeon'S Gloves | KGO | Class 1 | General, Plastic Surgery | No | 2019-09-25 |
Proprietary Names
Biogel PI UltraTouch S Surgical Glove
Biogel PI UltraTouch S Indicator Underglove
Establishment Types
Manufacture Medical Device