Shanghai Lejoy Co., Ltd.

Registered establishment in Shanghai, China. 21 device types.

Registry build 21.09.26

Shanghai Lejoy Co., Ltd. is an exporter holding a current FDA establishment registration. The registration covers Marker, Skin, Basin, Emesis and 19 other device types. Its earliest product listing with the FDA dates from 2023.

Registration

FDA registration record for Shanghai Lejoy Co., Ltd.
Registered name SHANGHAI LEJOY CO., LTD
Status Registered
Registration expires 2026
Registration number 3020468145
FEI number 3020468145
Establishment type Exporter

Location

Address of Shanghai Lejoy Co., Ltd.
City Shanghai
Province Shanghai
Address 757 Guangfu Road
Postal code 200070
Country China

What It Makes

Device types Shanghai Lejoy Co., Ltd. is registered to make
Device type Class Listed under the names Listed since Chinese makers
Accessory, Surgical Apparel Class 1 Accessory, Surgical Apparel 2023 439
Anti Fog Solution And Accessories, Endoscopy Class 2 Anti FOG Solution AND Accessories, Endoscopy; Laparoscope, General & Plastic Surgery 2023 5
Basin, Emesis Class 1 Basin, Emesis 2023 65
Catheter And Tip, Suction Class 2 Catheter AND TIP, Suction 2023 70
Component, Traction, Non-Invasive Class 1 Component, Traction, NON-Invasive 2023 18
Container, Liquid Medication, Graduated Class 1 Container, Liquid Medication, Graduated 2023 68
Electrosurgical, Cutting & Coagulation & Accessories Class 2 Electrosurgical, cutting & coagulation & accessories 2023 65
Fiber, Medical, Absorbent Class 1 Surgical Absorbent Mats 2023 172
Handle, Scalpel Class 1 Handle, Scalpel 2023 29
Instrument, Manual, Surgical, General Use Class 1 Instrument, Manual, Surgical, General USE 2023 110
Kit, Surgical Instrument, Disposable Class 1 Kit, surgical instrument, disposable 2023 67
Laparoscope, General & Plastic Surgery Class 2 Anti FOG Solution AND Accessories, Endoscopy; Laparoscope, General & Plastic Surgery 2023 46
Light, Surgical, Accessories Class 2 Light, surgical, accessories 2023 21
Marker, Skin Class 1 Marker, Skin 2023 55
Needle, Suturing, Disposable Class 1 Needle, Suturing, Disposable 2023 21
Non-Surgical Gown Class 1 NON-Surgical Isolation Gown 2023 318
Support, Patient Position Class 1 Support, Patient Position 2023 66
Syringe, Irrigating (Non Dental) Class 1 Syringe, Irrigating (NON Dental) 2023 110
Tape And Bandage, Adhesive Class 1 Tape and bandage, adhesive 2023 353
Tape, Measuring, Rulers And Calipers Class 1 Tape, Measuring, Rulers AND Calipers 2023 42
Tray, Surgical, Instrument Class 1 Tray, Surgical, Instrument 2023 105

Clearances

No clearance names Shanghai Lejoy Co., Ltd. as applicant. 4 are held by other companies and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.

510(k) clearances naming Shanghai Lejoy Co., Ltd. or its listings
Clearance Decision date Product code Route Held by
K182080 2018-09-19 GCJ Traditional Xodus Medical, Inc.
K102372 2010-11-03 GEI Traditional Jiangmen City Xinhui Baisheng Medical Equipment Co
K081647 2008-08-12 GEI Traditional Xodus Medical, Inc.
K053321 2006-01-19 FTA Traditional Xodus Medical, Inc.

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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.

The manufacturer named here can complete this record.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer