FDA Registration Active 🇫🇷 France

VSE8004XD - Empty Bag 600 ml 6-way man

Reg #: 3004404323 · FEI: 3004404323 · Expires 2025
Products
1
Proprietary Names
5
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
BK030008

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
Microfilter, Blood Transfusion CAK

Proprietary Names

VSE8004XD - Empty Bag 600 ml 6-way man VQE2001XD - 4 Empty Bags 300ML VSE3010XD - Empty Bag 300ML 6-Way Man VSL7000YD - Therapeutic Phlebotomy Bag VSL 7001PD - Therapeutic Phlebotomy Bag w/Needle

Establishment Types

Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Export Device to the United States But Perform No Other Operation on Device