Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011781201

FEI Number

3011781201

Entity Name

GUANGZHOU KOMASPEC MECHANICAL AND ELECTRICAL PRODUCTS MANUFA

City/State/Country

Huashan Town, Huadu District, Guangdong, CN

Establishment Address

Clifford (Huashan) Industrial City,# 288, A7 Ju Huashi Boulevard, Huashan Town, Huadu District, Guangdong 510880, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Guangzhou Komaspec Mechanical and Electrical Products Manufa (Owner Number: 10049466)

Owner / Operator Contact Address

Clifford (Huashan) Industrial ,# 288, A7 Ju Huashi Boulevard, Huashan Town, Huadu District,, CN-NOTA 510880, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

CytoSep Kool Plate

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KET	Filters, Cell Collection, Tissue Processing	Pathology	Class 1	864.3010	2015-06-04
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	Class 1	862.2050	2015-06-04
IDZ	Cassettes, Tissue	Pathology	Class 1	864.3010	2015-06-04
MXT	Device, Accessory, Cooling Plate For Tissue Embedding Station	Pathology	Class 1	864.3010	2024-04-05

Official Correspondent

No official correspondent registered.

US Agent Details

Erin St. Onge Business: Simport, Director of Sales and Business Development Email: erin.stonge@simport.com Phone: (843) 8226495

Related Public Records

Same Entity

Guangzhou Komaspec Mechanical and Electrical Products Manufa

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-0002-2008	Beckman Coulter Inc	1	FP1000 Cell Preparation System Software versions 1.1 & 1.2, Part Number 624922, for in vitro diagnostic use.
Z-0023-2013	Biomerieux Inc	1	PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham, NC. Intended to perform the inoculation and streaking of Prepoured Media (PPM) with liquid microbiological samples.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011781201. Last updated year: 2026. Please use registration number 3011781201 when referencing this establishment in official correspondence.