Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3020283264

FEI Number

3020283264

Entity Name

MEHOW INNOVATIVE (HUIZHOU) LTD.

City/State/Country

Huizhou Guangdong, CN

Establishment Address

No. 318, 3rd Longshan Road, Dayawan West District, Huizhou Guangdong 516083, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

MeHow Innovative (Huizhou) Ltd. (Owner Number: 10081772)

Owner / Operator Contact Address

No. 318, 3rd Longshan Road, Dayawan West District, Huizhou, CN-GD 516083, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

COCHLEAR OSIA MRI KIT Osia® 2 System Nucleus® 24 Cochlear Implant System Nucleus® Hybrid L24 Implant System Baha 5 Super Power Sound Processor Accessories

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2024-03-21
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2023-04-11
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2025-03-28
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2023-11-29
NOU	Continuous, Ventilator, Home Use	Anesthesiology	Class 2	868.5895	2024-03-21
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2024-03-21
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2023-04-11
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2026-03-05
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2024-03-21
MNR	Ventilatory Effort Recorder	Anesthesiology	Class 2	868.2375	2024-03-21
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2024-03-21
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2024-03-21
PFO	Active Implantable Bone Conduction Hearing System	Ear, Nose, Throat	Class 2	874.3340	2025-02-18
PFO	Active Implantable Bone Conduction Hearing System	Ear, Nose, Throat	Class 2	874.3340	2024-11-26
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2024-03-21
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2024-03-21
MCM	Implant, Cochlear	Unknown	Class 3	N/A	2024-11-25
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2024-03-21
PGQ	Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification	Unknown	Class 3	N/A	2024-11-26
LXB	Hearing Aid, Bone Conduction	Ear, Nose, Throat	Class 2	874.3302	2024-12-06

Official Correspondent

Na Sun

US Agent Details

Cancan Huang Business: OSMUNDA TECHNOLOGY CO., LTD. Email: sunny.huang@osmundacn.com Phone: (858) 3571157

Related Public Records

Same Entity

MeHow Innovative (Huizhou) Ltd.

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
K792722	Novametrix Medical Systems, Inc.	NOVAMETRIX CPAP NASAL CANNULA	1980-01-24
K082979	Resmed, Ltd.	S8 ADVANCE	2009-01-02
K203126	Resmed Pty , Ltd.	S10 Kirra	2020-12-18
K150445	Asahi Intecc Co., Ltd.	ASAHI Peripheral Guide Wire Series (ASAHI Gladius, ASAHI Halberd, ASAHI Gaia PV)	2015-06-30
K082922	Lake Region Mfg., Inc.	FREEWAY AND RAILRUNNER GUIDEWIRES	2008-12-09

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0009-2020	TELEFLEX-MORRISVILLE	2	Babi.Plus 12.5 cm H2O Pressure Relief Manifold Catalog # 2691 for use with ventilators.
Z-0020-2020	Galemed Corporation 87 Wu-Jia Li-Gong 2nd Road I-Lan Taiwan	2	Babi.Plus 12.5 cm H2O Pressure Relief Manifold, REF 1030, RX Only, UDI: 04710810093562
Z-0021-2020	Galemed Corporation 87 Wu-Jia Li-Gong 2nd Road I-Lan Taiwan	2	Babi.Plus Bubble PAP Valve with 12.5 cm H2O Pressure Relief Manifold, REF 1002, Rx Only, UDI: 24710810093559
Z-0022-2020	Galemed Corporation 87 Wu-Jia Li-Gong 2nd Road I-Lan Taiwan	2	Babi.Plus 12.5 cm H2O Pressure Relief Manifold with Gas Supply Tube and Oxygen Sensor Port, REF 2691, Rx Only, UDI: 04710810100802
Z-0030-2009	Boston Scientific Corporation	2	Platinum Plus" LT , REF 46-601, UPN M001466010, LT/0.018/180, Sterilized with ethylene oxide gas, Rx only, Legal Manufacturer Boston Scientific Corporation, One Boston scientific Place, Natick, MA 01760-1537, Made in USA: 8600 NW 41st Street, Miami, FL 33166-6202. The Platinum Plus" Guidewire facilitates placement of a catheter during diagnostic or interventional intravascular procedures. The wire can be torqued to facilitate navigation through tortuous arteries and/or avoid unwanted side branches.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3020283264. Last updated year: 2026. Please use registration number 3020283264 when referencing this establishment in official correspondence.