Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9710488

FEI Number

3005138167

Entity Name

MACOPRODUCTIONS S.A.S.

City/State/Country

TOURCOING Nord, FR

Establishment Address

200 CHAUSEE FERNAND FOREST, TOURCOING Nord 59200, FR

Establishment Type(s)

Manufacture Medical Device

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

BK030008

PMA Number

N/A

All Registered Proprietary Names

LCG2b with AS-1, AS-3 and AS-5 MacoMix HM20 and Hemolog 6 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 VSL7000YD - Therapeutic Phlebotomy Bag VSE8004XD - Empty Bag 600 ml 6-way man VQE2001XD - 4 Empty Bags 300ML VSE3010XD - Empty Bag 300ML 6-Way Man VSL 7001PD - Therapeutic Phlebotomy Bag w/Needle

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CAK	Microfilter, Blood Transfusion	General Hospital	Class 2	880.5440	2013-04-16
MYJ	Device, Mixing And Weighing, Semi-Automated	Hematology	Class 2	864.9195	2017-12-22
KSS	Supplies, Blood-Bank	Hematology	Class 1	864.9050	2018-01-05
CAK	Microfilter, Blood Transfusion	General Hospital	Class 2	880.5440	2008-01-28

Official Correspondent

No official correspondent registered.

US Agent Details

Tiffiney Teo Business: Macopharma USA Email: tiffiney@macopharmausa.com Phone: (770) 3806509

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
3004404323	MACO PHARMA	MOUVAUX Hauts-de-France, 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

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3037389071	GVS TM, INC.	Covina, CA, US
1066733	CHARTER MEDICAL, LLC	Winston Salem, NC, US
3017174574	GVS FILTER TECHNOLOGY DE MEXICO	Apodaca N.L Nuevo Leon, MX

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9710488. Last updated year: 2026. Please use registration number 9710488 when referencing this establishment in official correspondence.