Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015739059

FEI Number

3015739059

Entity Name

DONNEVIE MEDICAL TECHNOLOGY (SHANGHAI) CO.LTD

City/State/Country

Shanghai, CN

Establishment Address

Suite 101, 201 & 301,Bld 1, 138 Xinjun Ring, Minhang District, Shanghai 201114, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

DonneVie Medical Technology (Shanghai) Co.Ltd (Owner Number: 10060970)

Owner / Operator Contact Address

Suite 201,Bld 1, 138 Xinjun Ring, Minhang District, Shanghai, CN-SH 201114, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Micromanipulation Pipettes; Dewin Biopsy Pipette(D-BIOX); Dewin Holding Pipette(D-HOLD); Dewin Injection Pipette(D-ICSI) Micromanipulation Pipettes;Dewin Assisted Hatching Pipette(D-HATC);Dewin Zona Drilling Pipette(D-HPZD) Micromanipulation Pipettes;Dewin Denuding Pipette(D-DENU)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PUC	Microtools, Assisted Reproduction (Pipettes), Exempt	Obstetrics/Gynecology	Class 2	884.6130	2019-07-22

Official Correspondent

Xiang Li

US Agent Details

Donald Luongo Business: Astec Bio USA, Inc. Email: astecbiousa@gmail.com Phone: (617) 5108137

Related Public Records

Same Entity

DonneVie Medical Technology (Shanghai) 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 3015739059. Last updated year: 2026. Please use registration number 3015739059 when referencing this establishment in official correspondence.