Gemtier Medical (Shanghai) Inc.

FDA Device Registration & Listing · Shanghai, CN · Registration 3009746425

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3009746425
FEI Number
3009746425
Entity Name
Gemtier Medical (Shanghai) Inc.
City/State/Country
Shanghai, CN
Establishment Address
No. 18, Jianding Road, Fengjing Town,, Jinshan District, Shanghai 201502, CN
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Gemtier Medical (Shanghai) Inc. (Owner Number: 10041480)
Owner / Operator Contact Address
No. 18, Jianding Road, Fengjing Town,, Jinshan District, Shanghai, CN-SH 201502, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K170276
PMA Number
N/A

All Registered Proprietary Names

Safety Blood Collection Device for Single Use RELI

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2017-12-18
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2017-12-18

Official Correspondent

No official correspondent registered.

US Agent Details

Sanjiv Kumar Business: MYCO Medical Supplies, Inc. Email: sales@mycomedical.com Phone: (919) 4602535

Related Public Records

Same Entity

Gemtier Medical (Shanghai) Inc.
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
K812404 Nu Tech Medical Systems BUTTERFLY NEEDLE ASSEMBLY 1981-09-09
K221518 Np Medical NP Medical nCompass Extension Set with Stabilizing Base 2022-11-03
K953474 Medikmark, Inc. IV START KIT 1995-10-02
K972493 Nipro Medical Corp. NIPRO DISPOSABLE SOLUTION INFUSION SET 1997-09-18
K982672 Baxter Healthcare Corp COLLEAGUE PUMP SYRINGE ADAPTER SET 1998-09-04

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0002-2022 Bard Peripheral Vascular Inc 2
REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 10885403043796
Z-0010-2025 Smiths Medical ASD Inc. 2
CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24
Z-0011-2025 Smiths Medical ASD Inc. 2
CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24
Z-0012-2013 Baxter Healthcare Corp. Rt. 2
Baxter Interlink System Buretrol Solution Set with 150 mL Burette (Ball-Valve Drip Chamber); a sterile Rx IV fluid pathway device. Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.
Z-0012-2025 Smiths Medical ASD Inc. 2
CADD Medication Cassette Reservoir, 100mL, FS, YELLOW, Product Code 21-7300-24

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009746425. Last updated year: 2026. Please use registration number 3009746425 when referencing this establishment in official correspondence.
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