FDA Registration
Active
🇵🇭 Philippines
Haemonetics PCS2
Reg #: 3014982186
·
FEI: 3014982186
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- JMS HEALTHCARE PHL, INC.
- Registration Number
- 3014982186
- FEI Number
- 3014982186
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Lot 2-B-1, Phase 1B, First Philippine Industrial Park - Special Economic Zone
- City
- Tanauan City Batangas
- Country
- PH
Regulatory Submissions
- 510(k) Number
- BK950033
Owner / Operator
- Firm Name
- JMS HEALTHCARE PHL, INC.
- Operator Number
- 10059026
- Address
- Lot 2-B-1, Phase 1B, First Philippine Industrial Park - Special Economic Zone
- City
- Tanauan City
- State
- Batangas
- Postal Code
- 4232
- Country
- PH
- Correspondent
- Marolegrema B Angeles
US Agent
- Business Name
- JMS North America Corp.
- Contact Name
- Sho Hosoki
- Address
- 22320 Foothill Blvd. Suite 350
- City
- Hayward
- State
- CA
- ZIP
- 94541
- Country
- US
- [email protected]
- Phone
- 510 8889090 ext. 0
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Separator, Automated, Blood Cell, Diagnostic | GKT | Class 2 | Hematology | No | 2018-11-22 |
Proprietary Names
Haemonetics PCS2
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)
Manufacture Medical Device for Another Party (Contract Manufacturer)