Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013921506

FEI Number

3013921506

Entity Name

SUZHOU JENITEK MEDICAL CO., LTD.

City/State/Country

Suzhou Jiangsu, CN

Establishment Address

No. 70 Emeishan Road, SND, Suzhou Jiangsu 215153, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

SUZHOU JENITEK MEDICAL CO. LTD. (Owner Number: 10060234)

Owner / Operator Contact Address

No. 70 Emeishan Road, SND, Suzhou, CN-JS 215153, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Compression pads Pulse Generator Test Magnet JENITEK Torque Wrench

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MHW	Dressing, Compression	General Hospital	Class 1	880.5075	2022-04-21
OSR	Pacemaker/Icd/Crt Non-Implanted Components	Unknown	Class 3	N/A	2021-05-20
HXC	Wrench	Orthopedic	Class 1	888.4540	2024-11-17

Official Correspondent

No official correspondent registered.

US Agent Details

Tasha Bresnehan Business: ANA International, Inc. Email: Tasha.Bresnehan@anamotion.com Phone: (503) 4080203

Related Public Records

Same Entity

SUZHOU JENITEK MEDICAL 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-0033-2018	St Jude Medical Inc.	3	Merlin@Home Software Model EX2000 v8.2.2 for Merlin@Home Transmitter Models EX1150, EX1150W, EX1100, and EX1100W. The Merlin@home Transmitters are a component of St. Jude Medicals (SJM) Remote Care System. These Merlin@home transmitters are used to retrieve information from the SJM implantable medical device (IMD) using RF telemetry. The data is then sent back to the Merlin.net Patient Care Network through a built-in modem or, alternatively, through a USB cellular adapter or a USB based Broadband Kit. The transmitted data enables clinicians to remotely monitor a patients IMD using a secure, encrypted, password-protected web site, thus reducing the number of in-clinic visits a patient needs to make to their physician. The transmitter monitors the patients device daily between scheduled follow-ups and can alert a clinician if it detects anything out of the norm.

Similar Registrations

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3030691709	NextBeam	North Sioux City, SD, US
1043542	BRECON KNITTING MILL, INC.	Talladega, AL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013921506. Last updated year: 2026. Please use registration number 3013921506 when referencing this establishment in official correspondence.