Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1000610255

FEI Number

1000610255

Entity Name

MANATEC

City/State/Country

Poissy Ile-de-France, FR

Establishment Address

10 bis Rue Jacob Courant, Poissy Ile-de-France 78300, FR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Manatec SARL (Owner Number: 10028447)

Owner / Operator Contact Address

21 rue du Stade, Petit Ebersviller, FR-NOTA 57730, FR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K060387

PMA Number

N/A

All Registered Proprietary Names

PF07 Q-Link PhysioFlow Q-Link PhysioFlow System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DSB	Plethysmograph, Impedance	Cardiovascular	Class 2	870.2770	2014-06-27
DSB	Plethysmograph, Impedance	Cardiovascular	Class 2	870.2770	2009-01-30

Official Correspondent

Benoit Bosquet

US Agent Details

James Gunnerson Business: Eastern Rail Systems Email: jim.gunnerson@easternrail.com Phone: (215) 8269980

Related Public Records

Same Entity

Manatec SARL

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1000610255. Last updated year: 2026. Please use registration number 1000610255 when referencing this establishment in official correspondence.