Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009449769

FEI Number

3009449769

Entity Name

PROCARE INDUSTRIAL CO., LIMITED

City/State/Country

ZHENGZHOU Henan, CN

Establishment Address

Science Avenue 9, Hi-Tech Zone, ZHENGZHOU Henan 450000, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

PROCARE INDUSTRIAL CO., LIMITED (Owner Number: 10038360)

Owner / Operator Contact Address

Science Avenue 9, Hi-Tech Zone, Zhengzhou, Henan, 450000, China, ZHENGZHOU, CN-HA 450000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K162917

PMA Number

N/A

All Registered Proprietary Names

Allerhope Allergy Skin Tester

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	Class 1	880.6025	2011-10-08
KXG	Applicator, Absorbent Tipped, Sterile	General Hospital	Class 1	880.6025	2014-08-12
SCL	Allergen And Vaccine Delivery Needles	General Hospital	Class 2	880.5570	2026-01-30

Official Correspondent

No official correspondent registered.

US Agent Details

Vincent Zhou Business: Medwheat Inc. Email: vincent.zhou@medwheat.com Phone: (612) 8062995

Related Public Records

Same Entity

PROCARE INDUSTRIAL CO., LIMITED

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
K000299	Biomedex, Inc.	DERMAPIK II SKIN TEST SYSTEM, DERMAPIK II (SINGLE TEST DEVICE), POLYPIK II (MULTIPLE SKIN TEST DEVICE), DERMAPIK TRAY, D	2000-04-28

Similar Registrations

Registration Number	Establishment Name	Location
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3010615336	PODOPRO UK LTD	HUDDERSFIELD England, GB
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009449769. Last updated year: 2026. Please use registration number 3009449769 when referencing this establishment in official correspondence.