Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013938829

FEI Number

3013938829

Entity Name

ASOL CO.,LTD

City/State/Country

huaian Jiangsu, CN

Establishment Address

Room 1, Office Building, No. 2, Weike Road, Qingjiangpu District,, huaian Jiangsu 223005, CN

Establishment Type(s)

Manufacture Medical Device,Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

ASOL Co.,LTD (Owner Number: 10060679)

Owner / Operator Contact Address

Room 1, Office Building, No. 2, Weike Road, Qingjiangpu District,, 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

Forceps SCALPEL HANDLE Halstead mosquito forceps Scissors Needle Holde HOOK, OPHTHALMIC LACHRYMAL PROBE CALIPER, OPHTHALMIC Cannulas DILATOR, LACHRYMAL Rib Retractor Needle Holde Speculum Markers Forceps Scissors Clamp, General & Plastic Surgery

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HNR	Forceps, Ophthalmic	Ophthalmic	Class 1	886.4350	2019-06-11
GDZ	Handle, Scalpel	General, Plastic Surgery	Class 1	878.4800	2023-12-28
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2019-06-11
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	2019-06-11
HXK	Holder, Needle; Orthopedic	Orthopedic	Class 1	888.4540	2019-06-11
HNQ	Hook, Ophthalmic	Ophthalmic	Class 1	886.4350	2019-06-11
HNL	Probe, Lachrymal	Ophthalmic	Class 1	886.4350	2022-11-30
HOE	Caliper, Ophthalmic	Ophthalmic	Class 1	886.4350	2019-06-11
HMX	Cannula, Ophthalmic	Ophthalmic	Class 1	886.4350	2019-06-11
HNW	Dilator, Lachrymal	Ophthalmic	Class 1	886.4350	2019-12-29
FFO	Retractor, Self-Retaining	Gastroenterology, Urology	Class 1	876.4730	2022-11-30
FHQ	Holder, Needle, Gastroenterologic	Gastroenterology, Urology	Class 1	876.4730	2019-06-11
HNC	Specula, Ophthalmic	Ophthalmic	Class 1	886.4350	2019-06-11
HMR	Marker, Ocular	Ophthalmic	Class 1	886.4570	2019-06-11
GZX	Instrument, Microsurgical	Neurology	Class 1	882.4525	2019-06-11
HNF	Scissors, Ophthalmic	Ophthalmic	Class 1	886.4350	2019-06-11
GDJ	Clamp, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2020-12-08

Official Correspondent

Shujie Si

US Agent Details

Peter Yang Business: JIAMEI CONSULTING INC. Email: info@jiameiconsulting.com Phone: (310) 2168437

Related Public Records

Same Entity

ASOL 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
K854401	Microsurgical Technology, Inc.	THE NEW MOBILE TIP MCINTYRE CANNULA	1985-12-30

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0039-2018	Teleflex Medical	1	Pilling Knife Handles: a) REF 352950 b) REF 352953 c) REF 352951 d) REF 352957 e) REF 352952 : Reusable surgical knife handles, which are intended for use with blades which are inserted into a slot in the handle.
Z-0011-2019	Ellex iScience, Inc.	1	ellex I.Science iTRACK 250A, Canaloplasty Microcatheter Kit, for single use, REF iT-250A, Rx. The firm name on the label is Ellex iScience, Inc., Fremont, CA. Used in ophthalmic surgery.
Z-0022-2009	Becton Dickinson and Company	1	BD Visitec High Viscosity Injector, 4mm Ref: 585173. The product is intended for Vitroretinal Surgery.

Similar Registrations

Registration Number	Establishment Name	Location
2531819	LEAN & JONES, INC.	Jenkintown, PA, US
9710524	ULTIMATE MEDICAL PRODUCTS LTD.	SHARJAH Ash Shariqah, AE
3042228518	AKRITI OPHTHALMIC PRIVATE LIMITED	Hyderabad Telangana, IN
9612278	DUFNER INSTRUMENTE GMBH	TUTTLINGEN Baden-Wurttemberg, DE
3003039352	EPSILON EYE CARE PVT., LTD.	MUMBAI Maharashtra, IN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013938829. Last updated year: 2026. Please use registration number 3013938829 when referencing this establishment in official correspondence.