Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004404323

FEI Number

3004404323

Entity Name

MACO PHARMA

City/State/Country

MOUVAUX Hauts-de-France, FR

Establishment Address

233 RUE LORTHIOIS, --, MOUVAUX Hauts-de-France 59420, FR

Establishment Type(s)

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

Owner / Operator

MACO PHARMA (Owner Number: 9067788)

Owner / Operator Contact Address

233 RUE LORTHIOIS, --, MOUVAUX, FR-HDF 59420, FR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

BK170085

PMA Number

N/A

All Registered Proprietary Names

MacoMix HM20 and Hemolog 6 LCG2b with AS-1, AS-3 and AS-5 MACOSEAL PS2-AS MACOSEAL LIGHT SE160 9MPS2BRLAN: MacoPress Smart Smarter and DMS Ethernet Module - no breaker 9MPS2BIWIFI: MacoPress Smart Smarter and DMS WIFI Module - with breaker module for main press 9MPS2BRWIFI: MacoPress Smart Smarter and DMS WIFI Module - no breaker 9MPS2BILAN: MacoPress Smart Smarter and DMS Ethernet Module - with breaker module for main press 9MPSBRWIFI: MacoPress Smart and DMS WiFi Module - no breaker 9MPSBRLAN: MacoPress Smart and DMS Ethernet Module - no breaker 9MPSBIWIFI: MacoPress Smart and DMS WiFi Module - with breaker for main press 9MPSBILAN: MacoPress Smart and DMS Ethernet Module - with breaker for main press 9MPSBI485: MacoPress Smart and DMS RS485 Module - with breaker for main press 9MPSBR485: MacoPress Smart and DMS RS485 Module - no breaker

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MYJ	Device, Mixing And Weighing, Semi-Automated	Hematology	Class 2	864.9195	2017-12-22
CAK	Microfilter, Blood Transfusion	General Hospital	Class 2	880.5440	2013-04-16
KSD	Device, Heat-Sealing	Hematology	Class 1	864.9750	2009-10-15
KSS	Supplies, Blood-Bank	Hematology	Class 1	864.9050	2019-04-17
KSS	Supplies, Blood-Bank	Hematology	Class 1	864.9050	2018-01-05

Official Correspondent

No official correspondent registered.

US Agent Details

Tiffiney Teo Business: MACO PHARMA Email: tiffiney@macopharmausa.com Phone: (770) 2706867

Related Public Records

Same Entity

MACO PHARMA

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
9710488	MACOPRODUCTIONS S.A.S.	TOURCOING Nord, FR

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K873873	Travenol Laboratories, S.A.	RESUBMITTED MICRON TRANSFUSION FILTER	1987-10-22

Similar Registrations

Registration Number	Establishment Name	Location
9710488	MACOPRODUCTIONS S.A.S.	TOURCOING Nord, FR
3014345398	DELCON SRL	Grassobbio Bergamo, IT
9612051	FENWAL INTERNATIONAL, INC.	HAINA San Cristobal, DO
3014936217	HAEMOTRONIC DE MEXICO S DE RL	REYNOSA Tamaulipas, MX
3037389071	GVS TM, INC.	Covina, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004404323. Last updated year: 2026. Please use registration number 3004404323 when referencing this establishment in official correspondence.