FDA Registration Active 🇫🇷 France

9MPSBRLAN: MacoPress Smart and DMS Ethernet Module - no breaker

Reg #: 3004404323 · FEI: 3004404323 · Expires 2025
Products
1
Proprietary Names
6
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
BK170085

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
Phone
770 2706867

Products

Device Name Product Code
Supplies, Blood-Bank KSS

Proprietary Names

9MPSBRLAN: MacoPress Smart and DMS Ethernet Module - no breaker 9MPSBI485: MacoPress Smart and DMS RS485 Module - with breaker for main press 9MPSBIWIFI: MacoPress Smart and DMS WiFi Module - with breaker for main press 9MPSBR485: MacoPress Smart and DMS RS485 Module - no breaker 9MPSBRWIFI: MacoPress Smart and DMS WiFi Module - no breaker 9MPSBILAN: MacoPress Smart and DMS Ethernet Module - with breaker for main press

Establishment Types

Complaint File Establishment per 21 CFR 820.198 Export Device to the United States But Perform No Other Operation on Device Foreign Private Label Distributor