Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004434070

FEI Number

3004434070

Entity Name

HYPHEN BIOMED SASU

City/State/Country

NEUVILLE SUR OISE Val-d'Oise, FR

Establishment Address

155 RUE D ERAGNY, NEUVILLE SUR OISE Val-d'Oise 95000, FR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

HYPHEN BIOMED (Owner Number: 9067801)

Owner / Operator Contact Address

155 RUE D' ERAGNY, ZAC NEUVILLE - UNIVERSITE, NEUVILLE SUR OISE, FR-NOTA 95000, FR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K043007

PMA Number

N/A

All Registered Proprietary Names

AR021L Imidazole buffer 12x25 ml AR021K Imidazole buffer 3x25 ml AR021M Imidazole buffer 3x15ml AR021N Imidazole buffer 12x15ml AR021B Imidazole buffer 1x15ml BIOPHEN PROTEIN C5 BIOPHEN PROTEIN C 2.5 BIOPHEN HEPARIN 3 BIOPHEN HEPARIN 6 Biophen ACT PC-r Ctl Plasma(223405) Biophen VL Cal Undiluted (222401) Hemoclot Quanti V-L (CK065K) Biophen Normal Ctrl Plasma (223201) BIOPHEN ANTITHROMBIN 2.5 BIOPHEN ANTITROMBIN 5

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JCC	Ph Buffer	Pathology	Class 1	864.4010	2013-09-11
GGP	Test, Qualitative And Quantitative Factor Deficiency	Hematology	Class 2	864.7290	2008-11-28
KFF	Assay, Heparin	Hematology	Class 2	864.7525	2008-11-28
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2009-06-09
GGN	Plasma, Coagulation Control	Hematology	Class 2	864.5425	2009-06-09
GGW	Test, Time, Partial Thromboplastin	Hematology	Class 2	864.7925	2009-06-09
JBQ	Antithrombin Iii Quantitation	Hematology	Class 2	864.7060	2008-11-28

Official Correspondent

No official correspondent registered.

US Agent Details

Michele Washing Business: Aniara Diagnostica, Inc. Email: mwashing@aniara.com Phone: (513) 3422075

Related Public Records

Same Entity

HYPHEN BIOMED

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
K972288	Universal Reagents, Inc.	FACTOR DEFICIENT PLASMAS - FACTOR IX (9)	1997-07-14
K010379	Instrumentation Laboratory CO	IL TEST FREE PROTEIN S	2001-04-13
K033631	Instrumentation Laboratory CO	MODIFICATION TO COATEST FACTOR VIII	2003-12-15
K924884	Instrumentation Laboratory CO	IL TEST(TM) PRO-CHROM	1993-01-14
K042576	Instrumentation Laboratory CO	COATEST SP FVIII	2004-12-02

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0736-2016	Instrumentation Laboratory Co.	2	HemosIL Plasminogen, Part No. 0020009000, IVD. Instrumentation Laboratory Company. Kit contents: 2 x 2.5 mL Streptokinase reagent and 2 x 2 mL Chromogenic substrate
Z-1519-2012	Instrumentation Laboratory Co.	2	Instrumentation Laboratory (IL)HemosIL von Willebrand Factor Activity Assay Kit Part Number: 0020004700 The assay is intended for the quantitative determination of von Willebrand Factor Activity (VWF Activity) in human citrated plasma on IL Coagulation Systems
Z-0024-2007	Abbott Diagnostic International, Ltd. Carr 2 Km 58.0 Cruce Davila	2	FSH Calibrators (LN 9C06-01), for in vitro diagnostic use.
Z-0024-2015	Siemens Healthcare Diagnostics, Inc.	2	Dimension Vista Mass CKMB Isoenzyme Calibrator (MMB CAL) an in vitro diagnostic product for the calibration of Creatine Kinase MB Isoenzyme (MMB) method on the Dimension Vista System.
Z-0025-2007	Abbott Diagnostic International, Ltd. Carr 2 Km 58.0 Cruce Davila	2	Architect FSH Calibrators (LN 6C24-01), for in vitro diagnostic use.

Similar Registrations

Registration Number	Establishment Name	Location
3008344661	ABBOTT IRELAND	SLIGO, IE
1181121	Fisher Diagnostics	MIDDLETOWN, VA, US
1937990	SIGMA-ALDRICH MANUFACTURING, LLC-H&H	Saint Louis, MO, US
3004140393	BIOCARE MEDICAL, LLC	Pacheco, CA, US
2013736	MEDICAL CHEMICAL CORPORATION	TORRANCE, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004434070. Last updated year: 2026. Please use registration number 3004434070 when referencing this establishment in official correspondence.