Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008618183

FEI Number

3008618183

Entity Name

HUAIAN FRIMEN CO., LTD

City/State/Country

Huaian Jiangsu, CN

Establishment Address

No. 9 Haikou Road, Huaian Economic Development Zone, Huaian Jiangsu 223005, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Huaian Frimen Co., Ltd (Owner Number: 10042107)

Owner / Operator Contact Address

No. 9 Haikou Road, Huaian Economic, Development Zone, Huaian, CN-JS 223005, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

FRIMEN FRIMEN FRIMEN FRIMEN FRIMEN FRIMEN FRIMEN FRIMEN FRIMEN FRIMEN FRIMEN FRIMEN

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GEN	Forceps, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2020-09-16
HNC	Specula, Ophthalmic	Ophthalmic	Class 1	886.4350	2013-01-11
HNQ	Hook, Ophthalmic	Ophthalmic	Class 1	886.4350	2013-01-11
HNZ	Curette, Ophthalmic	Ophthalmic	Class 1	886.4350	2013-01-11
HNF	Scissors, Ophthalmic	Ophthalmic	Class 1	886.4350	2012-10-20
HOE	Caliper, Ophthalmic	Ophthalmic	Class 1	886.4350	2013-01-11
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	2020-09-16
HRQ	Hemostat	General, Plastic Surgery	Class 1	878.4800	2013-01-11
HNN	Knife, Ophthalmic	Ophthalmic	Class 1	886.4350	2012-10-20
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2019-12-20
HXK	Holder, Needle; Orthopedic	Orthopedic	Class 1	888.4540	2012-10-20
HNR	Forceps, Ophthalmic	Ophthalmic	Class 1	886.4350	2012-10-20

Official Correspondent

No official correspondent registered.

US Agent Details

Wilhelm Meryl Business: Katalyst Surgical LLC Email: meryl.wilhelm@zeiss.com Phone: (636) 5365950

Related Public Records

Same Entity

Huaian Frimen 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
K851170	The Huxley Instrument Corp.	DISSECTING TWEEZER #283-72PCS. SS 410	1985-04-25
K821248	Conphar, Inc.	ROCHESTER PEAN FORCEPS	1982-05-28
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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1421879	PHOENIX INSTRUMENTS, INC.	Lisle, IL, US
1123010	TRINITY STERILE, INC.	SALISBURY, MD, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008618183. Last updated year: 2026. Please use registration number 3008618183 when referencing this establishment in official correspondence.