FDA Registration
Active
🇬🇧 United Kingdom
The Parsortix® PC1 system
Reg #: 3014260469
·
FEI: 3014260469
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- ANGLE EUROPE LIMITED
- Registration Number
- 3014260469
- FEI Number
- 3014260469
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 10 Nugent Road, Surrey Research Park
- City
- Guildford, Surrey
- Country
- GB
Regulatory Submissions
- 510(k) Number
- DEN200062
Owner / Operator
- Firm Name
- ANGLE Europe Limited
- Operator Number
- 10085801
- Address
- 10 Nugent Road, Surrey Research Park
- City
- Guildford,
- State
- Surrey
- Postal Code
- GU2 7AF
- Country
- GB
- Correspondent
- Karen Miller
US Agent
- Business Name
- ANGLE North America Inc
- Contact Name
- Penny Lyons
- Address
- ANGLE North America Inc, 5100 Campus Drive Suite 120 Plymouth Meeting, PA
- City
- Plymouth Meeting
- State
- PA
- ZIP
- 19462
- Country
- US
- [email protected]
- Phone
- 610 2334712
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Circulating Tumor Cell (Ctc) Enrichment Device | QSA | Class 2 | Immunology | No | 2022-08-12 |
Proprietary Names
The Parsortix® PC1 system
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device