FDA Registration
Active
🇵🇭 Philippines
Pivot Hawks Manila, Inc.
Reg #: 1000655211
·
FEI: 1000655211
·
Expires 2026
Products
5
Proprietary Names
4
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- Pivot Hawks Manila, Inc.
- Registration Number
- 1000655211
- FEI Number
- 1000655211
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Lot 3-D, Unit 1-3, Greenfield Auto Park SEZ, Barangay Don Jose
- City
- Sta Rosa Laguna
- Country
- PH
Owner / Operator
- Firm Name
- Pivot International
- Operator Number
- 9107199
- Address
- Pivot International, 11030 Strang Line Road
- City
- Lenexa
- State
- KS
- Postal Code
- 66215
- Country
- US
US Agent
- Business Name
- MAE Group
- Contact Name
- Darshan Bhaiya
- Address
- 250 Commercial Street, Suite 3007
- City
- Manchester
- State
- NH
- ZIP
- 03101
- Country
- US
- [email protected]
- Phone
- 603 5050730
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Motor, Surgical Instrument, Ac-Powered | GEY | Class 1 | General, Plastic Surgery | No | 2010-05-13 |
| Devices, Breath Trapping, Alcohol | DJZ | Class 1 | Clinical Toxicology | No | 2025-04-23 |
| Operating Room Accessories Table Tray | FWZ | Class 1 | General, Plastic Surgery | No | 2018-07-19 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2011-12-08 |
| Stimulator, Nerve, Transcutaneous, For Pain Relief | GZJ | Class 2 | Neurology | No | 2023-02-02 |
Proprietary Names
Keepr
WalterLorenz Surgical Assist Arm
PAL Console 5020
BioWave GO Rx
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)