Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014457631

FEI Number

3014457631

Entity Name

SUZHOU JUNELAND MEDICAL CO., LTD.

City/State/Country

Suzhou Jiangsu, CN

Establishment Address

No.3, 5 Liuzhuang Road, Mudu Town, Wuzhong District, Suzhou Jiangsu 215000, CN

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer)

Owner / Operator

Suzhou Juneland Medical CO., LTD. (Owner Number: 10087367)

Owner / Operator Contact Address

No.3, 5 Liuzhuang Road, Mudu Town, Wuzhong District, Suzhou, CN-JS 215000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Irrigation Tube Suction Tube Implant Kit

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GBX	Catheter, Irrigation	General, Plastic Surgery	Class 1	878.4200	2023-02-17
JOL	Catheter And Tip, Suction	General Hospital	Class 2	880.6740	2023-02-17
KDD	Kit, Surgical Instrument, Disposable	General, Plastic Surgery	Class 1	878.4800	2023-02-17

Official Correspondent

XIAOLAN LU

US Agent Details

Anna Sun Business: SUN LUNA STAR LLC Email: usa@medpath.pro Phone: (626) 2005096

Related Public Records

Same Entity

Suzhou Juneland 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-0007-2013	Invuity, Inc.	2	BriteField illuminated Suction Device; Model numbers 8Fr, 10Fr and 12Fr, Kit (included 8Fr, 10Fr and 12Fr and a sterilization tray. The Invuity Brite Field Illuminated Suction Device is intended to aspirate from the surgical site and to provide illumination from a high intensity light source.

Similar Registrations

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3032912826	KMD SURGICAL SOLUTIONS, INC.	Winston Salem, NC, US
3017435705	CENTESE, INC.	Omaha, NE, US
1057421	GRACE MEDICAL, INC.	Memphis, TN, US
2521402	B. BRAUN MEDICAL INC.	BETHLEHEM, PA, US
2246552	Isomedix Operations Inc.	S Plainfield, NJ, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014457631. Last updated year: 2026. Please use registration number 3014457631 when referencing this establishment in official correspondence.