Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3034543750

FEI Number

3034543750

Entity Name

ENLIGHT MEDICAL TECHNOLOGIES (SHENZHEN) CO., LTD.

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

5-6/F, Building A, Xinghui Technology Industrial Park, 52 Huaning Road, Xinshi Community, Dalang Street, Longhua District, Shenzhen Guangdong 518109, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Enlight Medical Technologies (Shenzhen) Co., Ltd. (Owner Number: 10091943)

Owner / Operator Contact Address

5-6/F, Building A, Xinghui Technology Industrial Park, 52 Huaning Road, Xinshi Community, Dalang Street, Longhua District, Shenzhen, P.R. China, Shenzhen, CN-GD 518109, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K240871

PMA Number

N/A

All Registered Proprietary Names

WaveSelect Neurovascular Guidewire Synxess Neurovascular Guidewire Synxess

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MOF	Guide, Wire, Catheter, Neurovasculature	Cardiovascular	Class 2	870.1330	2024-12-03

Official Correspondent

No official correspondent registered.

US Agent Details

Aaron Zhang Email: aaron_zhang@enlight-medical.com Phone: (781) 2818648

Related Public Records

Same Entity

Enlight Medical Technologies (Shenzhen) 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 3034543750. Last updated year: 2026. Please use registration number 3034543750 when referencing this establishment in official correspondence.