Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013587414

FEI Number

3013587414

Entity Name

Hangzhou Careomedic Tech Co., Ltd.

City/State/Country

Hangzhou Zhejiang, CN

Establishment Address

Rm. 2-3-301-310, 55 Yifeng Rd, Qiantang District, Hangzhou Zhejiang 310018, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

Hangzhou Careomedic Tech Co.,Ltd (Owner Number: 10053819)

Owner / Operator Contact Address

Rm. 2-3-301-310, 55 Yifeng Rd, Qiantang District, Hangzhou, CN-ZJ 310018, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QKE	Immunoassay, Pregnanediol Glucuronide, Over The Counter	Clinical Chemistry	Class 1	862.1620	2022-02-15
LHD	Device, Fertility Diagnostic, Proceptive	Unknown	Class U	N/A	2023-02-03
JZT	Fluorometer	Immunology	Class 1	866.4520	2017-01-13
NGE	Test, Luteinizing Hormone (Lh), Over The Counter	Clinical Chemistry	Class 1	862.1485	2022-12-07

Official Correspondent

No official correspondent registered.

US Agent Details

Zheng Yang Business: Quanovate Tech Inc. Email: regulation@miracare.com Phone: (412) 5197085

Related Public Records

Same Entity

Hangzhou Careomedic Tech Co.,Ltd

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-0043-2024	Universal Meditech Inc.	1	One Step Ovulation Test REF 200-01

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013587414. Last updated year: 2026. Please use registration number 3013587414 when referencing this establishment in official correspondence.