Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3032143970

FEI Number

3032143970

Entity Name

VITAL HEALTHCARE (GUANGZHOU) CO., LTD.

City/State/Country

Guangzhou Guangdong, CN

Establishment Address

No.48 Xiangshan Avenue, Ningxi street, Zengcheng District, Guangzhou Guangdong 511338, CN

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer)

Owner / Operator

Vital Healthcare (Guangzhou) Co., Ltd. (Owner Number: 10091000)

Owner / Operator Contact Address

No.48 Xiangshan Avenue, Ningxi street, Zengcheng District, Guangzhou, CN-GD 511338, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

DORA NovaLine DORA

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FJK	Set, Tubing, Blood, With And Without Anti-Regurgitation Valve	Gastroenterology, Urology	Class 2	876.5820	2024-06-13
FJK	Set, Tubing, Blood, With And Without Anti-Regurgitation Valve	Gastroenterology, Urology	Class 2	876.5820	2024-06-13
FIE	Needle, Fistula	Gastroenterology, Urology	Class 2	876.5540	2024-06-13

Official Correspondent

Zoe Zeng

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

Vital Healthcare (Guangzhou) Co., Ltd.

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K915174	Jms Co., Ltd.	JMS APHERESIS NEEDLE	1993-03-02

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3032143970. Last updated year: 2026. Please use registration number 3032143970 when referencing this establishment in official correspondence.