Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007334784

FEI Number

3007334784

Entity Name

HUAIAN TISURG MEDICAL INSTRUMENTS CO., LTD.

City/State/Country

Huaian City Jiangsu, CN

Establishment Address

77 Jiujiang Road, Huaiyin District, Huaian City Jiangsu 223300, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

Huaian Tisurg Medical Instruments Co., Ltd. (Owner Number: 10027346)

Owner / Operator Contact Address

77 Jiujiang Road, Huaiyin District, Huaian City, CN-JS 223300, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Custom Tray Resin IBT Resin IBT Flex Resin H-0600 Resin

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HTE	Elevator	General, Plastic Surgery	Class 1	878.4800	2011-03-11
HNX	Depressor, Orbital	Ophthalmic	Class 1	886.4350	2011-03-11
HNB	Spoon, Ophthalmic	Ophthalmic	Class 1	886.4350	2011-03-11
EBH	Material, Impression Tray, Resin	Dental	Class 1	872.3670	2020-06-23
HNW	Dilator, Lachrymal	Ophthalmic	Class 1	886.4350	2011-03-11
HNN	Knife, Ophthalmic	Ophthalmic	Class 1	886.4350	2011-03-11
HNQ	Hook, Ophthalmic	Ophthalmic	Class 1	886.4350	2011-03-11
HNZ	Curette, Ophthalmic	Ophthalmic	Class 1	886.4350	2011-03-11
HNA	Spud, Ophthalmic	Ophthalmic	Class 1	886.4350	2011-03-11
HNH	Ring, Ophthalmic (Flieringa)	Ophthalmic	Class 1	886.4350	2011-03-11
DWS	Instruments, Surgical, Cardiovascular	Cardiovascular	Class 1	870.4500	2008-11-03
HNI	Retractor, Ophthalmic	Ophthalmic	Class 1	886.4350	2011-03-11
GES	Blade, Scalpel	General, Plastic Surgery	Class 1	878.4800	2011-03-11
HNL	Probe, Lachrymal	Ophthalmic	Class 1	886.4350	2011-03-11
HLN	Gauge, Lens, Ophthalmic	Ophthalmic	Class 1	886.1420	2011-03-11
HNC	Specula, Ophthalmic	Ophthalmic	Class 1	886.4350	2011-03-11
HOE	Caliper, Ophthalmic	Ophthalmic	Class 1	886.4350	2011-03-11
HND	Spatula, Ophthalmic	Ophthalmic	Class 1	886.4350	2011-03-11
HNF	Scissors, Ophthalmic	Ophthalmic	Class 1	886.4350	2015-09-24

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar corp Email: David.Lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

Huaian Tisurg Medical Instruments 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
K874057	Myocure, Inc.	OPHTHALMIC TIP & BLADE SCALPELS	1987-12-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0026-04	Surgical Specialties Corp	1	Sharpoint 2.75 mm x 3.75 mm ClearTrap Trapezoid Knife Clear Corneal Implant Angled. The product can be sold as an individual unit or in a box of 6 knives.
Z-1922-2024	Alcon Research LLC Aspex Facility	1	20 Gauge V-Lance Knife Model/Catalog Number: 8065912001 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
Z-1923-2024	Alcon Research LLC Aspex Facility	1	ClearCut Sideport Knife Dual Bevel 1.2mm Angled Model/Catalog Number: 8065921541 Software Version: N/A Product Description: Ophthalmic Knife Component: N/A
Z-1924-2024	Alcon Research LLC Aspex Facility	1	ClearCut S Safety Sideport Knife 1.0mm Dual Bevel Model/Catalog Number: 8065771540 Software Version: N/A Product Description: Ophthalmic Knife Component: N/A
Z-1925-2024	Alcon Research LLC Aspex Facility	1	ClearCut S Safety Sideport Knife 1.2mm Dual Bevel Model/Catalog Number: 8065771541 Software Version: N/A Product Description: Ophthalmic Knife Component: N/A

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007334784. Last updated year: 2026. Please use registration number 3007334784 when referencing this establishment in official correspondence.