Malosa Medical Instruments (Changshu) Limited
Registered establishment in Changshu, Jiangsu, China. 24 device types.
Malosa Medical Instruments (Changshu) Limited is a contract manufacturer holding a current FDA establishment registration. The registration covers Marker, Ocular, Marker, Sclera and 22 other device types. Its earliest product listing with the FDA dates from 2010.
Registration
| Status | Registered |
|---|---|
| Registration expires | 2026 |
| Registration number | 3012733432 |
| FEI number | 3012733432 |
| Establishment type | Contract manufacturer, Manufacturer |
Location
| City | Changshu |
|---|---|
| Province | Jiangsu |
| Address | No. 62 Suzhou Road |
| Postal code | 215500 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Caliper, Ophthalmic | Class 1 | Castroviejo Caliper | 2019 | 8 |
| Cannula, Ophthalmic | Class 1 | Vitreoretinal Cannula, BVI Ophthalmic Cannula, Anterior Chamber Cannula [Rycroft], Bimanual Irrigation Cannula, Anterior Chamber Cannula, Olive Tip Polisher and 42 more | 2010 | 6 |
| Clamp, Eyelid, Ophthalmic | Class 1 | Malosa Chalazion, Chalazion Clamp, Oval, Medium, Chalazion Clamp Round, Chalazion Clamp Oval | 2010 | 3 |
| Corneal Inlay Inserter Handle | Class 1 | Corneal Ring Pusher | 2020 | 2 |
| Curette, Ophthalmic | Class 1 | Chalazion Curette Double 02mm/03mm, Chalazion Curette, Chalazion Curette, Double, 01mm/02mm | 2010 | 8 |
| Depressor, Orbital | Class 1 | Ball Tip Scleral Depressor, Schocket Double-Ended Scleral Depressor, Curved Scleral Depressor, VR Double-Ended Depressor/Indentor, Triangular Scleral Depressor | 2020 | 3 |
| Forceps, Ophthalmic | Class 1 | Iris Pointed Forceps, Colibri Toothed Forceps, Colibri Notched Forceps, Toothed Forceps (Bonn), Toothed Forceps, Birks Tying Forceps and 54 more | 2010 | 12 |
| Guide, Needle, Surgical | Class 1 | Nivert Needle-Holder, Halsey Needle-Holder, Derf Needle-Holder, Barraquer Needle-Holder, Troutman Needle-Holder, Castroviejo Needle-Holder and 4 more | 2013 | 32 |
| Handle, Scalpel | Class 1 | Beaver Handle, Dynagrip Handle and Wrench 4mm, Beaver BeaverTail Flat Handle, Barron Scalpel Handle Flat, Beaver Blade Wrench, Beaver Replacement Chuck Collet and 4 more | 2010 | 29 |
| Hook, Ophthalmic | Class 1 | Ursell Chopper/Manipulator, Hagege Manipulator, Sinskey Hook Straight, Phaco Chopper, LASIK Flap Elevator Curved, Corneal Ring Pocketing Hook and 49 more | 2010 | 11 |
| Hook, Surgical, General & Plastic Surgery | Class 1 | Gillies Skin Hook | 2020 | 19 |
| Instrument, Manual, Surgical, General Use | Class 1 | LASIK Flap Separator, ReLEx Pocketing Hook/Separator, LASIK Flap Separator/Elevator, X-Ray Pointer, Micro Retractor, Pearce, 30 degrees, Eye Guard and 29 more | 2012 | 110 |
| Marker, Ocular | Class 1 | Toric Marker, Horizontal Axis Marker, Visitec® Visimark™ Corneal Marking Pad, Y Shape Corneal Marker, S Marker, Mendez Gauge and 1 more | 2010 | 7 |
| Marker, Sclera | Class 1 | Braunstein IVT Marker, Double Ended IVT Guide Pad, Pointed IVT Marker, Intravitreal Injection Guide, Pointed IVT Marker 3.5/4mm, Blue, Braunstein IVT Marker, 3.5/4mm | 2016 | 3 |
| Probe, Lachrymal | Class 1 | Lacrimal Probe, Punctum Seeker, Bowmans Probes, Size 00-0, Visitec Reuable Insertion Instrument, Bowmans Probes, Punctum Dilator and 3 more | 2010 | 6 |
| Punch, Corneo-Scleral | Class 1 | Trabeculectomy Punch Titanium | 2010 | 3 |
| Retractor, Ophthalmic | Class 1 | Cats Paw Retractor, Langenbach Retractor, Fisons Retractor, Desmarres Lid Retractor, Small, Desmarres Lid Retractor, Medium, Desmarres Lid Retractor and 1 more | 2010 | 8 |
| Scissors, Ophthalmic | Class 1 | Nurses Blunt Scissors, Sharp Blunt Scissors, Metzenbaum Scissors, Westcott Scissors, Dressing Scissors, Vannas Scissors and 22 more | 2010 | 14 |
| Spatula, Ophthalmic | Class 1 | Spatula, Daya Descemets Scraper, Corneal Epithelium Spatula, Corneal Epithelium Spatula, Round, Spatula, [Pearce],.80mm (45 Degree), Barraquer Iris Spatula and 2 more | 2010 | 9 |
| Specula, Ophthalmic | Class 1 | Corcelle Speculum Solid Blade, Paediatric Mechanical Speculum, Mechanical Speculum, Barraquer Speculum, Infant Speculum, Sauer Neonatal Speculum and 17 more | 2010 | 11 |
| Spoon, Ophthalmic | Class 1 | Paton Spatula/Spoon, Double-Ended Evisceration Spoon, Evisceration Spoon | 2010 | 7 |
| Spud, Ophthalmic | Class 1 | Golf Club Spud | 2010 | 4 |
| Surgical Eye Tray | Class 1 | Malosa Core Surface Treatment Pack, Readypak, Malosa Core Phaco Pack, Malosa Oculoplastic Suture Pack, Malosa Phaco Kit, Malosa Sub-Tenons Pack and 10 more | 2021 | 3 |
| Trephine, Manual, Ophthalmic | Class 1 | Beaver Troutman Corneal Punch Piston, Beaver Replacement Teflon Block, Beaver Iowa P.K. Press, Beaver Iowa P.K. Press Cutting Block, Corneal Trephine, Lacrimal Trephine | 2010 | 2 |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
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