Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9681574

FEI Number

3001137417

Entity Name

Hemodia SAS

City/State/Country

Labege Haute-Garonne, FR

Establishment Address

85 Rue du Chene vert, Labege Haute-Garonne 31670, FR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Hemodia SAS (Owner Number: 9024682)

Owner / Operator Contact Address

85 Rue de Chene Vert, --, Labege, FR-NOTA 31670, FR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K203480

PMA Number

N/A

All Registered Proprietary Names

DOUBLEFLO DOUBLEFLO

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2023-03-15
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2021-04-09

Official Correspondent

No official correspondent registered.

US Agent Details

Van der Woude Michael Business: Emergo Global Representation LLC Email: USAgent@ul.com Phone: (512) 3279997

Related Public Records

Same Entity

Hemodia SAS

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K081051	Spine View, Inc.	SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS), SPINEVU MINISCOPE	2008-08-07
K820777	The Anspach Effort, Inc.	MINI-MICRO ARTHROSCOPIC SCAPEL	1982-05-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0041-05	Linvatec Corp.	2	Ultra Power Burs, Sterile, Single-Use.

Similar Registrations

Registration Number	Establishment Name	Location
3044858680	JIENO YOUCHENG MEDICAL TECHNOLOGY (SHANGHAI) CO., LTD.	Shanghai, CN
1650907	Isomedix Operations Inc.	GRAND PRAIRIE, TX, US
3014615697	AMNOTEC INTERNATIONAL MEDICAL GMBH	Neuhausen ob Eck Baden-Wurttemberg, DE
3043226252	ZAPALIGN LLC	Fort Lauderdale, FL, US
3020978007	DONGGUAN BAO KANG DIAN ZI KE JI LIMITED	Dongguan City Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9681574. Last updated year: 2026. Please use registration number 9681574 when referencing this establishment in official correspondence.