Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1225991

FEI Number

3002516348

Entity Name

LYOPHILIZATION SERVICES OF NEW ENGLAND, INC.

City/State/Country

MANCHESTER, NH, US

Establishment Address

1 Sundial Ave Ste 112, MANCHESTER, NH 03103, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Lyophilization Services of New England, Inc. (Owner Number: 9031362)

Owner / Operator Contact Address

25 Commerce Drive, --, Bedford, NH 03110, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names were found for this listing. DURAFORM Dural Graft Implant CardaMend Pericardial and Epicardial Reconstruction Matrix

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DXC	Clamp, Vascular	Cardiovascular	Class 2	870.4450	2008-01-08
KGN	Wound Dressing With Animal-Derived Material(S)	Unknown	Class U	N/A	2021-12-14
LMF	Agent, Absorbable Hemostatic, Collagen Based	General, Plastic Surgery	Class 3	878.4490	2008-01-08
GXQ	Dura Substitute	Neurology	Class 2	882.5910	2016-01-13
PSQ	Intracardiac Patch Or Pledget, Biologically Derived	Cardiovascular	Class 2	870.3470	2022-12-22

Official Correspondent

Mindy Gagnon

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Lyophilization Services of New England, Inc.

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
K112888	Kensey Nash Corporation	MESO WOUND MATRIX	2012-02-10
K040211	Collagen Matrix, Inc.	MODIFICATION TO: COLLAGEN TOPICAL WOUND DRESSING	2004-02-27

Similar Registrations

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1055236	DEROYAL INDUSTRIES, INC.	NEW TAZEWELL, TN, US
2950160	WRIGHT ENGINEERED PLASTICS, INC.	Santa Rosa, CA, US
3005809810	Jarit GmbH	Rietheim-Weilheim Baden-Wurttemberg, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1225991. Last updated year: 2026. Please use registration number 1225991 when referencing this establishment in official correspondence.