FDA Registration
Active
🇲🇽 Mexico
Sion Biotext Mexico, S.A.P.I. De C.V.,
Reg #: 3035479692
·
FEI: 3035479692
·
Expires 2025
Products
1
Proprietary Names
0
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Sion Biotext Mexico, S.A.P.I. De C.V.,
- Registration Number
- 3035479692
- FEI Number
- 3035479692
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Avenida Centenario, No. 5, Esquina Andador 11 Este y 56 Sur, Lote 12 y 5 Manzana 1
- City
- Civac Mexico
- Country
- MX
Regulatory Submissions
- 510(k) Number
- K201309
Owner / Operator
- Firm Name
- Sion Biotext Mexico, S.A.P.I. De C.V.
- Operator Number
- 10092513
- Address
- Avenida Centenario, No. 5, Esquina Andador 11 Este y 56 Sur, Lote 12 y 5 Manzana 1,
- City
- Civac
- State
- Mexico
- Postal Code
- 62578
- Country
- MX
US Agent
- Business Name
- mdi Consultants Inc
- Contact Name
- Alan Schwartz
- Address
- 55 Northern Blvd Ste 200
- City
- Great Neck
- State
- NY
- ZIP
- 11021
- Country
- US
- [email protected]
- Phone
- 516 4829001
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Block, Bite | JXL | Class 2 | Neurology | No | 2025-03-06 |
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)