Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009558349

FEI Number

3009558349

Entity Name

TESSY PLASTICS SHANGHAI CO., LTD

City/State/Country

SHANGHAI, CN

Establishment Address

BUILDING 9, #509 REN QING ROAD, SHANGHAI 201201, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

TESSY PLASTICS SHANGHAI CO., LTD (Owner Number: 10041479)

Owner / Operator Contact Address

BUILDING 9, #509 REN QING ROAD, SHANGHAI, CN-SH 201201, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Pro-Matrix VISTASEAL Dual Applicator VISTASEAL DUAL APPLICATOR

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JEP	Retainer, Matrix	Dental	Class 1	872.4565	2020-08-20
FCH	Tray, Biopsy, Without Biopsy Instruments	Gastroenterology, Urology	Class 1	876.4730	2024-06-12
MZM	Fibrin Sealant Preparation Device	General Hospital	Class 2	880.5860	2019-06-14
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2012-07-29

Official Correspondent

Nils Hammerich

US Agent Details

Nils Hammerich Hammerich Email: nhammerich@tessysh.com Phone: (315) 6893924

Related Public Records

Same Entity

TESSY PLASTICS SHANGHAI CO., 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
K831136	Almore Intl., Inc.	DOUBLE BOW TOOTH SEPARATOR	1983-06-08
K900590	Biosearch Medical Products, Inc.	BIOSEARCH DOBBHOFF(R) GASTROTRAC JEJUNAL FEEDING	1990-08-02
K102548	Footprint Medical, Inc.	FOOTPRINT MEDICAL POLYURETHANE FEEDING TUBE	2010-11-26
K955248	United States Endoscopy Group, Inc.	U.S. ENDOSCOPY PULL PEG KIT & U.S. ENDOSCOPY GUIDEWIRE PEG KIT	1996-05-21
K872921	Medical Support, Inc.	MSS ENTERAL DELIVERY SET	1987-12-03

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3003956316	COMMIC SURGICO	SIALKOT Punjab, PK
8043622	RICHBOLT ENTERPRISES	SIALKOT Punjab, PK
9611367	HELMUT ZEPF MEDIZINTECHNIK GMBH	SEITINGEN Baden-Wurttemberg, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009558349. Last updated year: 2026. Please use registration number 3009558349 when referencing this establishment in official correspondence.