Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3038611403

FEI Number

3038611403

Entity Name

BLOODSCAN BIOTECH INC.

City/State/Country

Nangang Dist. Taipei, TW

Establishment Address

C414, No. 99, Ln. 130, Sec. 1, Academia Rd.,, Nangang Dist. Taipei 115021, TW

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility,Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

Bloodscan Biotech Inc. (Owner Number: 10093480)

Owner / Operator Contact Address

C414, No. 99, Ln. 130, Sec. 1, Academia Rd.,, Nangang Dist., TW-TPE 115021, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Labyrinth One

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PER	Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis	Clinical Chemistry	Class 1	862.2750	2025-05-22

Official Correspondent

Chiping Chang

US Agent Details

Eric Lin Email: gogodidi0@gmail.com Phone: (415) 2728646

Related Public Records

Same Entity

Bloodscan Biotech Inc.

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

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0009-2025	Becton, Dickinson and Company, BD Bio Sciences	1	BD FACSDuet Premium Sample Preparation System, REF: 666340, 666339; and BD FACSDuet Sample Preparation System (Base), REF: 663128, 662588, used with software V 1.4.1. Intended use: to prepare human specimens to be analyzed.

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3027394506	Becton, Dickinson and Company, BD Biosciences	Milpitas, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3038611403. Last updated year: 2026. Please use registration number 3038611403 when referencing this establishment in official correspondence.