Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3031696823

FEI Number

3031696823

Entity Name

Vitrafy Laboratory and Manufacturing Centre

City/State/Country

Wendouree Victoria, AU

Establishment Address

45 Selkirk Drive, Wendouree Victoria 3355, AU

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Vitrafy Life Sciences Limited (Owner Number: 10091137)

Owner / Operator Contact Address

45 Selkirk Drive, Ballarat, AU-VIC 3182, AU

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Vitrafy Cryopreservation Unit

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KSE	Refrigerator, Freezer, Blood Storage	Hematology	Class 2	864.9700	2024-07-10

Official Correspondent

Brent Owens

US Agent Details

Krystal Santiago Email: krystal@santiagoengineers.com Phone: (310) 7075882

Related Public Records

Same Entity

Vitrafy Life Sciences Limited

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3031696823. Last updated year: 2026. Please use registration number 3031696823 when referencing this establishment in official correspondence.