Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3025460034

FEI Number

3025460034

Entity Name

SUZHOU LABYRINTH BIOTECH CO., LTD

City/State/Country

Suzhou Jiangsu, CN

Establishment Address

218 Xinghu Street, A7 Building, Suite 505-506, Industry Park District, Suzhou Jiangsu 215123, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Suzhou Labyrinth Biotech Co., Ltd (Owner Number: 10086590)

Owner / Operator Contact Address

218 Xinghu Street, A7 Building, Suite 505-506, Industry Park District, Suzhou, CN-JS 215123, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Cell Sorting Device Disposable Cells Collector and Storage

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GKH	Apparatus, Automated Blood Cell Diluting	Hematology	Class 1	864.5240	2022-11-22
NNK	Container, Specimen Mailer And Storage, Non-Sterile	Pathology	Class 1	864.3250	2022-11-22

Official Correspondent

Ruby Chen

US Agent Details

James Wang Business: LLINS TECHNOLOGY INC Email: fda-rep@llins-tech.com Phone: (720) 2171916

Related Public Records

Same Entity

Suzhou Labyrinth Biotech Co., Ltd

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 3025460034. Last updated year: 2026. Please use registration number 3025460034 when referencing this establishment in official correspondence.