GENZYME COPORATION

FDA Device Registration & Listing · Northborough, MA, US · Registration 3009389940

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3009389940
FEI Number
3009389940
Entity Name
GENZYME COPORATION
City/State/Country
Northborough, MA, US
Establishment Address
11 Forbes Road, Northborough, MA 01532, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
GENZYME CORPORATION (Owner Number: 9002116)
Owner / Operator Contact Address
450 Water Street, Cambridge, MA 02141, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Laronidase reagent Alglucosidase alfa reagent Agalsidase beta reagent Imiglucerase reagent Anti-acid alpha-glucosidase reagent Olipudase alpha reagent Avalglucosidase alfa reagent

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MVU Reagents, Specific, Analyte Pathology Class 1 864.4020 2008-01-10

Official Correspondent

Kathleen Holdren

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

GENZYME CORPORATION
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
1220423 GENZYME CORPORATION FRAMINGHAM, MA, US
3039908023 GENZYME CORPORATION Ridgefield, NJ, US

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009389940. Last updated year: 2026. Please use registration number 3009389940 when referencing this establishment in official correspondence.
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