Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008819649

FEI Number

3008819649

Entity Name

MP Biomedicals Asia Pacific Pte Ltd

City/State/Country

Singapore Central Singapore, SG

Establishment Address

2 Pioneer Place, Singapore Central Singapore 627885, SG

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

MP BIOMEDICALS LLC (Owner Number: 9057708)

Owner / Operator Contact Address

29525 FOUNTAIN PARKWAY, Solon, OH 44139, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

MP Diagnostics HTLV Blot 2.4 HTLV Blot 2.4 MPD HTLV Blot 2.4

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OTR	Research Use Only/Immunology Devices	Unknown	Class N	N/A	2013-07-09

Official Correspondent

Walter Zawadzkas

US Agent Details

Walter Zawadzkas Business: MP Biomedicals LLC Email: walter.zawadzkas@mpbio.com Phone: (440) 2017563

Related Public Records

Same Entity

MP BIOMEDICALS LLC

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
2419955	MP BIOMEDICALS DIAGNOSTICS DIVISION	Solon, OH, US

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008819649. Last updated year: 2026. Please use registration number 3008819649 when referencing this establishment in official correspondence.