Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3021639773

FEI Number

3021639773

Entity Name

ZHUHAI LONGTIME BIOLOGICAL TECHNOLOGY CO., LTD.

City/State/Country

Zhuhai City Guangdong, CN

Establishment Address

Rm1301, Building No. 3 Tsinghua Science Park, Zhuhai City Guangdong 519080, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Zhuhai Longtime Biological Technology Co., Ltd. (Owner Number: 10087765)

Owner / Operator Contact Address

Rm1301, Building No. 3 Tsinghua Science Park, Zhuhai City, CN-GD 519080, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Single-use Sterile Mixing and Spray Applicator (model: 10ml) Plasma preparation centrifuge (model: LT-GD01, LT-GL01, LT-CD01, LT-CL01) PRP Mixer (model: LTM01)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KYZ	Syringe, Irrigating (Non Dental)	General Hospital	Class 1	880.6960	2025-07-15
QBV	Centrifuge For Preparation Of Cell Concentrate And/Or Plasma Concentrate	Clinical Chemistry	Class 1	862.2050	2025-07-15
GLE	Mixer, Blood Tube	Clinical Chemistry	Class 1	862.2050	2025-07-15

Official Correspondent

No official correspondent registered.

US Agent Details

Linda Chen Business: Dynasty Medical Consulting Inc. Email: usagent@chonconn.com Phone: (832) 3809688

Related Public Records

Same Entity

Zhuhai Longtime Biological Technology 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 3021639773. Last updated year: 2026. Please use registration number 3021639773 when referencing this establishment in official correspondence.