Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008754084

FEI Number

3008754084

Entity Name

Belle Healthcare Technology Co., Ltd.

City/State/Country

Suzhou Jiangsu, CN

Establishment Address

Building 3, No.300 Qing Cheng Shan Road,SND, Suzhou Jiangsu 215163, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Belle Healthcare Technology Co., Ltd. (Owner Number: 10034664)

Owner / Operator Contact Address

Building 3, No300, Qing Cheng Shan Rd., SND, Suzhou, CN-JS 215153, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Belle Healthcare Belle Healthcare Belle Healthcare Magnetic Foreign Body Extractor Belle Healthcare Belle Healthcare Belle Healthcare Belle Healthcare Amniotic Membrane Implantation Device Belle Healthcare Belle Healthcare Belle Healthcare Belle Healthcare Magnetic Foreign Body Extractor Disposable Trocar Kit Belle Healthcare Belle Healthcare

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HMX	Cannula, Ophthalmic	Ophthalmic	Class 1	886.4350	2010-12-21
HNQ	Hook, Ophthalmic	Ophthalmic	Class 1	886.4350	2011-01-06
HNZ	Curette, Ophthalmic	Ophthalmic	Class 1	886.4350	2010-12-21
HNA	Spud, Ophthalmic	Ophthalmic	Class 1	886.4350	2024-12-18
HNL	Probe, Lachrymal	Ophthalmic	Class 1	886.4350	2010-12-21
HNI	Retractor, Ophthalmic	Ophthalmic	Class 1	886.4350	2011-01-06
HNM	Needle, Ophthalmic Suturing	Ophthalmic	Class 1	886.4350	2011-03-25
HOE	Caliper, Ophthalmic	Ophthalmic	Class 1	886.4350	2011-01-06
QGJ	Corneal Inlay Inserter Handle	Ophthalmic	Class 1	886.4355	2024-12-18
HMR	Marker, Ocular	Ophthalmic	Class 1	886.4570	2010-12-21
HNW	Dilator, Lachrymal	Ophthalmic	Class 1	886.4350	2010-12-21
HND	Spatula, Ophthalmic	Ophthalmic	Class 1	886.4350	2010-12-21
HNN	Knife, Ophthalmic	Ophthalmic	Class 1	886.4350	2011-01-06
MXY	Cannula, Ophthalmic, Posterior Capsular Polishing, Polyvinyl Acetal	Ophthalmic	Class 1	886.4350	2024-12-18
NGY	Cannula, Trocar, Ophthalmic	Ophthalmic	Class 1	886.4350	2024-12-05
HNH	Ring, Ophthalmic (Flieringa)	Ophthalmic	Class 1	886.4350	2011-01-06
HNK	Probe, Trabeculotomy	Ophthalmic	Class 1	886.4350	2024-12-18
HNC	Specula, Ophthalmic	Ophthalmic	Class 1	886.4350	2011-01-06

Official Correspondent

Jumin Li

US Agent Details

Dongchun Liang Business: Liang Email: Mikebear919@gmail.com Phone: (626) 3818855

Related Public Records

Same Entity

Belle Healthcare Technology 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
K874057	Myocure, Inc.	OPHTHALMIC TIP & BLADE SCALPELS	1987-12-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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.
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

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9611502	CARL TEUFEL GMBH & CO. KG	LIPTINGEN Baden-Wurttemberg, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008754084. Last updated year: 2026. Please use registration number 3008754084 when referencing this establishment in official correspondence.