Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012733432

FEI Number

3012733432

Entity Name

Malosa Medical Instruments (Changshu) Limited

City/State/Country

Changshu Jiangsu, CN

Establishment Address

No. 62 Suzhou Road, High-tech Industry Park, Changshu Jiangsu 215500, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Beaver-Visitec International, Inc. (Owner Number: 10033379)

Owner / Operator Contact Address

500 Totten Pond Rd, 10 CityPoint, Waltham, MA 02451, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Curved Scleral Depressor Ball Tip Scleral Depressor Schocket Double-Ended Scleral Depressor Triangular Scleral Depressor VR Double-Ended Depressor/Indentor Castroviejo Caliper Barron Scalpel Handle Flat Beaver Blade Wrench Dynagrip Handle and Wrench 4mm Artho-Lok Handle and Wrench 4mm Beaver Handle (Round Knurled Stainless) Beaver BeaverTail Flat Handle Lens Handle Scalpel Blade Handle With Gradations Beaver Handle Beaver Replacement Chuck Collet Trabeculectomy Punch Titanium Vannas Scissors Dressing Scissors Metzenbaum Scissors Castroviejo Corneoscleral Scissors Enucleation Scissors Westcott Scissors, Straight, Pointed Castroviejo Scissors Iris Scissors Curved Iris Scissors Nurses Blunt Scissors Mayo Scissors Stevens Tenotomy Westcott Scissors, Curved, Pointed Westcott Scissors Sharp Blunt Scissors Iris Dissecting Scissors Vannas Scissors, Curved IOL Cutter (Osher) Dressing Scissors, Straight, Rounded Ong Capsule Scissors Westcott Scissors, Straight, Rounded Castroviejo Scissors, Straight, Rounded Westcott Scissors, Curved, Dolphin Nose Vannas Scissors, Straight Iris Scissors, Curved, Pointed Stevens Tenotomy, Straight, Rounded Clip - Sprung Scissors (Pair) Clip - Micro Sprung Scissors (Pair) Corneal Ring Pusher Chalazion Curette Double 02mm/03mm Chalazion Curette Chalazion Curette, Double, 01mm/02mm Castroviejo Needle-Holder Without Lock Castroviejo Needle-Holder Halsey Needle-Holder Corneal Needle-Holder Nivert Needle-Holder Barraquer Needle-Holder Castroviejo Needle-Holder, Curved Crile Murray Needle-Holder Derf Needle-Holder Troutman Needle-Holder Pointed IVT Marker Intravitreal Injection Guide Braunstein IVT Marker, 3.5/4mm Braunstein IVT Marker Double Ended IVT Guide Pad Pointed IVT Marker 3.5/4mm, Blue Y Shape Corneal Marker Horizontal Axis Marker Toric Marker Double-Ring Corneal Marker Visitec® Visimark Corneal Marking Pad Mendez Gauge S Marker Ayliffe Chopper/Chopper Claw Chopper Kuglen Hook Greens Chopper Sadiq Chopper Ursell Chopper/Manipulator Corneal Ring Pocket Spreader Epithelium Hoe Denis Nucleus Chopper Vertical Y Manipulator Drysdale Manipulator Diablo Manipulator Mushroom Manipulator Epithelium Hoe Curved Button Manipulator LASIK Flap Elevator Curved Reverse Sinskey Butcher Rotator ICL Manipulator Button Tip Manipulator, (45 Degree) Horizontal Chopper/Kuglen Hook Govan Manipulator Flat Round Tip Manipulator LASIK Flap Elevator Pointed Greens Chopper, Right Handed Koch Chopper, 1.4mm, Thin Shaft Hagege Manipulator Horizontal Y Manipulator Sinskey Hook Straight Corneal Ring Pocketing Hook Phaco Chopper/Mushroom Manipulator Sinskey Hook Ball Tip Muscle Hook Seibel Nucleus Chopper Nagahara Chopper Rosen Chopper Neuhann Nucleus Divider McPherson Manipulator Diablo Chopper/Flat Button Manipulator Curved Muscle Hook Phaco Chopper Chevasse Muscle Hook Koch Chopper, 1.4mm Reverse Dialling Hook Koch Chopper 1.4mm/Button Manipulator Lester Hook Lebuisson Manipulator Kuglen Hook Angled Sinskey Hook, 0.2mm Kuglen Hook, Straight Nucleus Chopper, [P.Koch], (45 Degree) Micro Iris Hooks, [Engels], 8mm long x 8mm diameter IOL Manipulator, [Lester], .25mm IOL Manipulator, [Sinskey], Blunt tip Nucleus Rotator Visitec Reuable Insertion Instrument Lacrimal Probe Bowmans Probes Punctum Dilator Punctum Dilator/Lacrimal Probe Bowmans Probes, Size 00-0 Punctum Seeker Punctum Dilator, Medium Canaliculus Intubation Set (CIS) Gillies Skin Hook Chalazion Clamp Round Chalazion Clamp Oval Malosa Chalazion Chalazion Clamp, Oval, Medium BVI Ophthalmic Cannula Bishop Harmon Cannula Small Incision Irrigating Vectis Transcleral Drainage Cannula LASIK Flap Irrigator Posterior Scraper Cortex Extractor ViscoExpression Cannula Visitec Nucleus Hydrodissector Irrigating Cannulas Infusion Cannulas LASIK Flap Spatula/Irrigator Anterior Chamber Cannula Anterior Chamber Cannula [Rycroft] Silicone Oil Removal Cannula Micro Irrigating Vectis Tapered Hydrodelineator Membrane Micropick Visitec Irrigation Handle 50 Cannula Viscoflow® Cannula High Viscosity Injector I and A Cannula Vitreoretinal Brush LASIK Cannula Lacrimal Cannula Coaxial I and A Cannula Leatherbarrow Pellet Insertion Cannula 5 SP Vitreoretinal Cannula Capsule Polisher HydroExpression Cannula Sub-Tenons Anesthesia Cannula Micro J Shape Hydrodissector Subretinal Injector FLACS Cannula J Shape Cannula Olive Tip Cannula LASEK Cannula Nucleus Hydrodissector LASIK Irrigating Cannula Subretinal Fluid Cannula Micro J Shape Cannula Soft Tip Cannula Irrigating Vectis Cortical Cleaving Hydrodissector Olive Tip Polisher Flexible Tip Cannula Bimanual Irrigation Cannula Corneal Epithelium Spatula Spatula PRK Spatula Daya Descemets Scraper Barraquer Iris Spatula Corneal Epithelium Spatula, Round Spatula, [Pearce], .80mm (45 Degree) Excimer Spatula, Lindstrom / Vorkas

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HNX	Depressor, Orbital	Ophthalmic	Class 1	886.4350	2020-05-26
HOE	Caliper, Ophthalmic	Ophthalmic	Class 1	886.4350	2019-08-15
GDZ	Handle, Scalpel	General, Plastic Surgery	Class 1	878.4800	2010-08-11
HNJ	Punch, Corneo-Scleral	Ophthalmic	Class 1	886.4350	2010-08-17
HNF	Scissors, Ophthalmic	Ophthalmic	Class 1	886.4350	2010-08-11
QGJ	Corneal Inlay Inserter Handle	Ophthalmic	Class 1	886.4355	2020-05-27
HNZ	Curette, Ophthalmic	Ophthalmic	Class 1	886.4350	2010-08-11
GDF	Guide, Needle, Surgical	General, Plastic Surgery	Class 1	878.4800	2013-07-25
HMQ	Marker, Sclera	Ophthalmic	Class 1	886.4570	2016-07-11
HMR	Marker, Ocular	Ophthalmic	Class 1	886.4570	2010-08-11
HNQ	Hook, Ophthalmic	Ophthalmic	Class 1	886.4350	2010-08-11
HNL	Probe, Lachrymal	Ophthalmic	Class 1	886.4350	2010-08-11
GDG	Hook, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2020-05-27
HOD	Clamp, Eyelid, Ophthalmic	Ophthalmic	Class 1	886.4350	2010-08-11
HMX	Cannula, Ophthalmic	Ophthalmic	Class 1	886.4350	2010-08-10
HND	Spatula, Ophthalmic	Ophthalmic	Class 1	886.4350	2010-08-11

Official Correspondent

No official correspondent registered.

US Agent Details

Silvana Brown Business: Beaver-Visitec International, Inc. Email: regulatory@bvimedical.com Phone: (952) 7377242

Related Public Records

Same Entity

Beaver-Visitec International, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3012539515	Rio Bravo International Inc	El Paso, TX, US
2247224	Beaver-Visitec International, Inc	Little Silver, NJ, US
3013466775	Grupo American Industries, S.A. de C.V	Ciudad Juarez Chihuahua, MX
3013421458	Beaver-Visitec International, Inc.	Ciudad Juarez Chihuahua, MX
9680620	Beaver-Visitec International, Ltd	BIDFORD-ON-AVON Warwickshire, GB

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K871646	Ocular Instruments, Inc.	TANNE CORNEAL CUTTING BLOCK	1987-05-18
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.

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8040381	INDO-GERMAN SURGICAL CORPORATION	Mumbai Maharashtra, IN
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012733432. Last updated year: 2026. Please use registration number 3012733432 when referencing this establishment in official correspondence.