Biomat USA, Inc.

FDA Device Registration & Listing · City of Industry, CA, US · Registration 3005488132

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
3005488132
FEI Number
3005488132
Entity Name
Biomat USA, Inc.
City/State/Country
City of Industry, CA, US
Establishment Address
13111 Temple Ave., City of Industry, CA 91746, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Biomat USA, Inc. (Owner Number: 10035627)
Owner / Operator Contact Address
2410 Grifols Way, Los Angeles, CA 90032, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
BK180240
PMA Number
N/A

All Registered Proprietary Names

GDS (Grifols Donation System) V2 GDS (Grifols Donation System, version 1

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MMH Blood Establishment Computer Software And Accessories Hematology Class 2 864.9165 2021-01-27
MMH Blood Establishment Computer Software And Accessories Hematology Class 2 864.9165 2018-11-29

Official Correspondent

Marcela Magalhaes

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Biomat USA, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Similar Registrations

Registration Number Establishment Name Location
3009166014 KEDRION S.P.A. Barga (Castelvecchio Pascoli) Lucca, IT
3006129391 WellSky Corporation. - Headquarters Overland Park, KS, US
3017199812 GPI USA, INC. Houston, TX, US
3020696801 CieloWorks Austin, TX, US
1058332 SCC SOFT COMPUTER CLEARWATER, FL, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005488132. Last updated year: 2026. Please use registration number 3005488132 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.