FDA Registration
Active
🇺🇸 United States
LYOPHILIZATION SERVICES OF NEW ENGLAND, INC.
Reg #: 1225991
·
FEI: 3002516348
·
Expires 2026
Products
6
Proprietary Names
3
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- LYOPHILIZATION SERVICES OF NEW ENGLAND, INC.
- Registration Number
- 1225991
- FEI Number
- 3002516348
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1 Sundial Ave Ste 112
- City
- MANCHESTER
- State
- NH
- ZIP
- 03103
- Country
- US
Owner / Operator
- Firm Name
- Lyophilization Services of New England, Inc.
- Operator Number
- 9031362
- Address
- 25 Commerce Drive, --
- City
- Bedford
- State
- NH
- Postal Code
- 03110
- Country
- US
- Correspondent
- Mindy - Gagnon
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Clamp, Vascular | DXC | Class 2 | Cardiovascular | No | 2008-01-08 |
| Wound Dressing With Animal-Derived Material(S) | KGN | Class U | Unknown | No | 2021-12-14 |
| Agent, Absorbable Hemostatic, Collagen Based | LMF | Class 3 | General, Plastic Surgery | No | 2008-01-08 |
| Dura Substitute | GXQ | Class 2 | Neurology | No | 2016-01-13 |
| Intracardiac Patch Or Pledget, Biologically Derived | PSQ | Class 2 | Cardiovascular | No | 2022-12-22 |
| Filler, Bone Void, Calcium Compound | MQV | Class 2 | Orthopedic | No | 2015-12-15 |
Proprietary Names
No proprietary names were found for this listing.
DURAFORM Dural Graft Implant
CardaMend Pericardial and Epicardial Reconstruction Matrix
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)