Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003927385

FEI Number

3003927385

Entity Name

JDI ELECTRONICS FACTORY

City/State/Country

Dongguan Guangdong, CN

Establishment Address

Sima Industrial District, Sima Village, Chang Ping Town, Dongguan Guangdong 523570, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Blue Ocean Innovation Limited (Owner Number: 9054823)

Owner / Operator Contact Address

Unit 50, 8/F Wah Lok Industrial Centre Phase 2 Blk F,, 31-35 Shan Mei Street., FOTAN, HK-NOTA --, HK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

SoClean 3+ Bacterial Reduction Device IHS-needle set (#637) Cefaly #629 IHS Series SoClean 3+ Bacterial Reduction Device CEFALY DUAL Enhanced CEFALY Connected and CeCe Migraine Management App

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QXQ	Respiratory Accessory Microbial Reduction Device.	General Hospital	Class 2	880.6993	2025-02-05
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2021-12-12
PCC	Stimulator, Nerve, Electrical, Transcutaneous, For Migraine	Neurology	Class 2	882.5891	2022-12-18
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2024-05-29
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2024-05-29
PKP	Immunoglobulin G (Igg) Infusion System	General Hospital	Class 2	880.5725	2024-05-29
QXQ	Respiratory Accessory Microbial Reduction Device.	General Hospital	Class 2	880.6993	2025-11-16
PCC	Stimulator, Nerve, Electrical, Transcutaneous, For Migraine	Neurology	Class 2	882.5891	2021-03-17
PCC	Stimulator, Nerve, Electrical, Transcutaneous, For Migraine	Neurology	Class 2	882.5891	2024-08-07
LRJ	Disinfectant, Medical Devices	General Hospital	Class 1	880.6890	2014-06-25

Official Correspondent

SAM LEE

US Agent Details

PETER TAM Business: PETER TAM-ENGINEERING CONSULTANT Email: PTIUSA@EARTHLINK.NET Phone: (949) 4000888

Related Public Records

Same Entity

Blue Ocean Innovation 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
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
K143446	Roche Diagnostics GmbH	Accu-Chek FlexLink Plus infusion set	2015-08-13

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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
Z-0013-2013	Baxter Healthcare Corp. Rt.	2	Baxter Interlink System Buretrol Solution Set, 117" (3.0 m), with 150 mL Burette (Ball-Valve Drip Chamber) (Non-DEHP); 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.

Similar Registrations

Registration Number	Establishment Name	Location
3009534409	SoClean, Inc.	Peterborough, NH, US
3018229072	INNOVATIVE HEALTH SCIENCES	Chester, NY, US
3030989877	INTERNATIONAL FILTER PRODUCTS DBA IFP MEDICAL	Sun Valley, CA, US
1047843	ISOMEDIX OPERATIONS INC.	SPARTANBURG, SC, US
3002807090	Sterigenics Germany GmbH	Wiesbaden Hesse, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003927385. Last updated year: 2026. Please use registration number 3003927385 when referencing this establishment in official correspondence.