Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3027978412

FEI Number

3027978412

Entity Name

RENOLIT HANSEN PACKAGING TECH. (BJ) LTD.

City/State/Country

Beijing, CN

Establishment Address

NO.22 Yanqi Street, Huairou Economic Development District, Beijing 101407, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

RENOLIT Hansen Packaging Tech. (BJ) Ltd. (Owner Number: 10088611)

Owner / Operator Contact Address

NO.22 Yanqi Street, Huairou Economic Development District, Beijing, CN-BJ 101407, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

SINEFIX

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2023-08-29

Official Correspondent

Jennifer Zhang

US Agent Details

John Hernandez Business: American RENOLIT Corporation LA Email: john.hernandez@renolit.com Phone: (323) 7257010

Related Public Records

Same Entity

RENOLIT Hansen Packaging Tech. (BJ) 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
K193295	Parcus Medical, LLC	Parcus Knotless PEEK and PEEK CF Push-In Suture Anchor	2020-01-23
K193606	Conmed Corporation	Y-Knot OneStep Anchor	2020-01-22
K984200	R. Thomas Grotz, M.D., Inc.	STABILIZER SOFT TISSUE ANCHOR, 5 AND 8MM; ANCHOR INSERTER, 5 AND 8MM; STABILIZER DRILL, 5 AND 8MM, NONSTERILE; STABILIZE	1999-01-21
K171060	Riverpoint Medical	OrthoButton AL	2017-06-02
K231867	Paragon 28, Inc.	Grappler Suture Anchor System	2023-08-21

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3011989923	DIAFARMA ECZA DEPOSU VE MEDIKAL DIS TICARET DIS TIC LTD STI	Istanbul, TR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3027978412. Last updated year: 2026. Please use registration number 3027978412 when referencing this establishment in official correspondence.