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Genzyme Corp.

United States·US-MF-000007947

Last updated September 17, 2026

Information

Country: United States
Address: 1125, Pleasant View Terrace, Ridgefield, United States
Website: sanofi.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1 570 390 9072
PRRC Contact: Sandra Ahern
EUDAMED SRN: US-MF-000007947
FDA FEI Number: 3039908023
DUNS Number: —

Catalogue (47)

Device	Model / Reference	Registries	Class	Status
Seprafilm®	4301-02	FDA UDI	Class III	Active
Seprafilm® Procedure Pack	5086-02	FDA UDI	Class III	Active
LeGoo® LG250	LG250	FDA UDI	Class III	Unknown
Seprafilm® Small Incision	6642-01	FDA UDI	Class III	Active
Olipudase 20mg/5ml Medsu Vl1 Diag Us	785362	FDA UDI	Class I	Active
Aldurazyme 2.9 Mg/5ml Medsu Vl1 Diag Us	762618	FDA UDI	Class I	Active
Seprafilm® Single Site	6641-01	FDA UDI	Class III	Active
Seprafilm® 4-section	6380-01	FDA UDI	Class III	Active
Synvisc-One®	002401	FDA UDI	Class III	Active
Gaa-1 Antibody 1mg/1ml Medsu Vl1 Diag Us	762617	FDA UDI	Class I	Active
Synvisc®	002390	FDA UDI	Class III	Active
Cerezyme 400iu Medsu Vl1 Diag Us	762621	FDA UDI	Class I	Active
LeGoo® LG100	LG100	FDA UDI	Class III	Unknown
Neogaa Avalgluco 100mg/20ml Medsu Vl1 Us	785361	FDA UDI	Class I	Active
Myozyme 50mg/10ml Medsu Vl1 Diag Us	762619	FDA UDI	Class I	Active
Fabrazyme 35mg/7ml Vl1 Diag Us	762620	FDA UDI	Class I	Active
Synvisc	Not Applicable	EUDAMED	Class III	Active
N-Geneous Wide Range Crp Reagent And Calibrator Set	K040241	FDA 510(k)	Class II	Active
Genzyme Direct Amylase Verifier	K993132	FDA 510(k)	Class II	Active
N-Geneous Ldl-St Cholesterol Reagent, N-Geneous Ldl-St Cholesterol Calibrator, Genzyme Ldl Cholesterol Control Set	K992766	FDA 510(k)	Class I	Active
Amylase Reagent	K921057	FDA 510(k)	Class II	Active
Genzyme Contrast Ii Hcg Urine/Serum Test	K023544	FDA 510(k)	Class II	Active
Genzyme Direct-Amylase Test Reagent	K011843	FDA 510(k)	Class II	Active
Liquid N-Geneous Hdl Cholesterol Kit/Calibrator	K971162	FDA 510(k)	Class I	Active
N-Geneous Hdl Cholesterol Kit/Cholesterol Calibrator	K962186	FDA 510(k)	Class I	Active
Osom Influenza A&B Test	K061508	FDA 510(k)	Class II	Active
Glypro Reagent, Glypro Calibrator, Glypro Low Control, Glypro High Control	K000239	FDA 510(k)	Class II	Active
Genzyme A-Amylase Test Reagent	K933397	FDA 510(k)	Class II	Active
Cottony Ii, Silky Ii Polydek & Tevdek Ii Polyester Suture	K021019	FDA 510(k)	Class II	Active
Sepramesh Biosurgical Composite, Model Smbc-Xxx	K994328	FDA 510(k)	Class II	Active
Direct Ldl Cholesterol Immunoseparation Reagent Kit	K943150	FDA 510(k)	Class I	Active
Predicta Erythropoietin Kit	K926390	FDA 510(k)	Class II	Active
Hdl Cholesterol Reagent	K911406	FDA 510(k)	Class I	Active
Glypro Reagent, Glypro Calibrator, Glypro Low Control, Glypro High Control	K983726	FDA 510(k)	Class II	Active
Sepramesh Ip Bioresorbable Barrier - Permanent Mesh	K040868	FDA 510(k)	Class II	Active
Genzyme Osom Trichomonas Rapid Test	K033864	FDA 510(k)	Class I	Active
Direct Ldl Choles Immunoseparation Reagent	K924674	FDA 510(k)	Class I	Active
Amylase Reagent	K912519	FDA 510(k)	Class II	Active
Predicta Erythropoietin Kit (modification)	K954898	FDA 510(k)	Class II	Active
Ultra N-Geneous Hdl Cholesterol Reagent 1/Reagent2; Ultra N-Geneous Hdl Cholestreol Calibrator	K021316	FDA 510(k)	Class I	Active
Sepragel Sinus	K012532	FDA 510(k)	Class I	Active
N-Geneous Hdl Cholesterol Kit/Cholesterol Calibrator	K971190	FDA 510(k)	Class I	Active
N-Geneous Ldl Cholesterol Reagent, N-Geneous Ldl Cholesterol Calibrator, Genzyme Ldl Cholesterol Control Set	K971573	FDA 510(k)	Class I	Active
Genzyme Osom Influenza A & B Test	K051244	FDA 510(k)	Class II	Active
Synvisc	Not Applicable	EUDAMED	Class III	Active
Legoo	P110003	FDA PMA	Class III	Active
Focalseal-L Synthetic Absorbable Sealant	P990028	FDA PMA	Class II	Active

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FDA Recalls (9)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Jun 13, 2012	Z-1856-2012	—	terminated	Sterility of product may be compromised due to packaging defect
Jun 13, 2012	Z-1855-2012	—	terminated	Sterility of product may be compromised due to packaging defect
Jul 13, 2010	Z-2310-2010	—	terminated	Revised Labeling of Carticel Essentials Kit clarifies the non-sterile packaging of the outer clear plastic tray which should not be opened in the sterile field.
Apr 14, 2008	Z-2151-2008	—	terminated	Calibration and Quality Control outside of established range resulting from an increase in initial OD readings with the reagent contained within the kits.
Apr 14, 2008	Z-2150-2008	—	terminated	Calibration and Quality Control outside of established range resulting from an increase in initial OD readings with the reagent contained within the kits.
Apr 14, 2008	Z-2149-2008	—	terminated	Calibration and Quality Control outside of established range resulting from an increase in initial OD readings with the reagent contained within the kits.
Apr 14, 2008	Z-2148-2008	—	terminated	Calibration and Quality Control outside of established range resulting from an increase in initial OD readings with the reagent contained within the kits.
Apr 10, 2008	Z-1647-2008	—	terminated	Sterility may be compromised
Apr 10, 2008	Z-1648-2008	—	terminated	Sterility may be compromised