ASTEC BIO USA INC

FDA Device Registration & Listing · Hingham, MA, US · Registration 3015529470

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
3015529470
FEI Number
3015529470
Entity Name
ASTEC BIO USA INC
City/State/Country
Hingham, MA, US
Establishment Address
10 Keith Way, Suite 3, Hingham, MA 02043, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
Astec Bio USA Inc (Owner Number: 10060831)
Owner / Operator Contact Address
10 Keith Way, Suite 3, Hingham, MA 02043, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

ASTEC Holding Pipette ASTEC Blastomere Biopsy Pipette ASTEC Zona Drilling Pipette ASTEC ICSI Injection Pipette ASTEC PZD ASTEC ICSI Injection Pipette with Smoothed Jaw

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
PUC Microtools, Assisted Reproduction (Pipettes), Exempt Obstetrics/Gynecology Class 2 884.6130 2020-07-09

Official Correspondent

Donald Luongo

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Astec Bio USA Inc
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 3015529470. Last updated year: 2026. Please use registration number 3015529470 when referencing this establishment in official correspondence.
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