FDA Registration
Active
🇫🇷 France
9MPS2BILAN: MacoPress Smart Smarter and DMS Ethernet Module - with breaker module for main press
Reg #: 3004404323
·
FEI: 3004404323
·
Expires 2025
Products
1
Proprietary Names
4
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- MACO PHARMA
- Registration Number
- 3004404323
- FEI Number
- 3004404323
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 233 RUE LORTHIOIS, --
- City
- MOUVAUX Hauts-de-France
- Country
- FR
Regulatory Submissions
- 510(k) Number
- BK180306
Owner / Operator
- Firm Name
- MACO PHARMA
- Operator Number
- 9067788
- Address
- 233 RUE LORTHIOIS, --
- City
- MOUVAUX
- State
- Hauts-de-France
- Postal Code
- 59420
- Country
- FR
US Agent
- Business Name
- MACO PHARMA
- Contact Name
- Tiffiney Teo
- Address
- 3075 Breckinridge Blvd Ste 405
- City
- Duluth
- State
- GA
- ZIP
- 30096
- Country
- US
- [email protected]
- Phone
- 770 2706867
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Supplies, Blood-Bank | KSS | Class 1 | Hematology | No | 2019-04-17 |
Proprietary Names
9MPS2BILAN: MacoPress Smart Smarter and DMS Ethernet Module - with breaker module for main press
9MPS2BRWIFI: MacoPress Smart Smarter and DMS WIFI Module - no breaker
9MPS2BIWIFI: MacoPress Smart Smarter and DMS WIFI Module - with breaker module for main press
9MPS2BRLAN: MacoPress Smart Smarter and DMS Ethernet Module - no breaker
Establishment Types
Foreign Private Label Distributor
Complaint File Establishment per 21 CFR 820.198
Export Device to the United States But Perform No Other Operation on Device