Altasciences CDMO Philadelphia, LLC

FDA Device Registration & Listing · Harleysville, PA, US · Registration 3007884119

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
3007884119
FEI Number
3007884119
Entity Name
Altasciences CDMO Philadelphia, LLC
City/State/Country
Harleysville, PA, US
Establishment Address
1510 Delp Drive, 1508 Delp Drive, Harleysville, PA 19438, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Altasciences CDMO Philadelphia, LLC (Owner Number: 10059529)
Owner / Operator Contact Address
1510 Delp Drive, Harleysville, PA 19438, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

GEM 21S® Growth-Factor Enhanced Matrix

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NPZ Bone Grafting Material, Dental, With Biologic Component Dental Class 3 872.3930 2019-01-30
NQA Biologic Material, Dental Dental Class 3 872.3930 2019-01-30

Official Correspondent

Daniel Sciola

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Altasciences CDMO Philadelphia, LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007884119. Last updated year: 2026. Please use registration number 3007884119 when referencing this establishment in official correspondence.
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