FDA Registration
Active
🇨🇳 China
SHANGHAI LEJOY CO., LTD
Reg #: 3020468145
·
FEI: 3020468145
·
Expires 2026
Products
21
Proprietary Names
20
Establishment Types
1
Classifications
21
Registration Details
- Registration Name
- SHANGHAI LEJOY CO., LTD
- Registration Number
- 3020468145
- FEI Number
- 3020468145
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 757 Guangfu Road, Minmetals Building
- City
- Shanghai
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K053321
Owner / Operator
- Firm Name
- Shanghai Lejoy Co., LTD
- Operator Number
- 10088511
- Address
- 757 Guangfu Road, Minmetals Building
- City
- Shanghai
- State
- CN-SH
- Postal Code
- 200070
- Country
- CN
- Correspondent
- Peter Chen
US Agent
- Business Name
- XODUS MEDICAL INC
- Contact Name
- Paul Lloyd
- Address
- 702 Prominence Drive
- City
- New Kensington
- State
- PA
- ZIP
- 15068
- Country
- US
- [email protected]
- Phone
- 724 3375500
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Support, Patient Position | CCX | Class 1 | Anesthesiology | No | 2023-11-03 |
| Light, Surgical, Accessories | FTA | Class 2 | General, Plastic Surgery | No | 2023-11-03 |
| Non-Surgical Gown | OEA | Class 1 | General, Plastic Surgery | No | 2023-11-03 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2023-11-03 |
| Container, Liquid Medication, Graduated | KYW | Class 1 | General Hospital | No | 2023-11-03 |
| Marker, Skin | FZZ | Class 1 | General, Plastic Surgery | No | 2023-11-03 |
| Handle, Scalpel | GDZ | Class 1 | General, Plastic Surgery | No | 2023-11-03 |
| Basin, Emesis | FNY | Class 1 | General Hospital | No | 2023-11-03 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2023-11-03 |
| Fiber, Medical, Absorbent | FRL | Class 1 | General Hospital | No | 2023-08-21 |
| Kit, Surgical Instrument, Disposable | KDD | Class 1 | General, Plastic Surgery | No | 2023-11-03 |
| Needle, Suturing, Disposable | GAB | Class 1 | General, Plastic Surgery | No | 2023-11-03 |
| Component, Traction, Non-Invasive | KQZ | Class 1 | Orthopedic | No | 2023-11-03 |
| Syringe, Irrigating (Non Dental) | KYZ | Class 1 | General Hospital | No | 2023-11-03 |
| Catheter And Tip, Suction | JOL | Class 2 | General Hospital | No | 2023-11-03 |
| Tape, Measuring, Rulers And Calipers | FTY | Class 1 | General, Plastic Surgery | No | 2023-11-03 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2023-11-03 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2023-11-03 |
| Anti Fog Solution And Accessories, Endoscopy | OCT | Class 2 | Gastroenterology, Urology | No | 2023-11-03 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2023-11-03 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2023-11-03 |
Proprietary Names
SUPPORT, PATIENT POSITION
Light, surgical, accessories
NON-SURGICAL ISOLATION GOWN
TRAY, SURGICAL, INSTRUMENT
CONTAINER, LIQUID MEDICATION, GRADUATED
MARKER, SKIN
HANDLE, SCALPEL
BASIN, EMESIS
Electrosurgical, cutting & coagulation & accessories
Surgical Absorbent Mats
Kit, surgical instrument, disposable
NEEDLE, SUTURING, DISPOSABLE
COMPONENT, TRACTION, NON-INVASIVE
SYRINGE, IRRIGATING (NON DENTAL)
CATHETER AND TIP, SUCTION
TAPE, MEASURING, RULERS AND CALIPERS
Tape and bandage, adhesive
ANTI FOG SOLUTION AND ACCESSORIES, ENDOSCOPY; LAPAROSCOPE, GENERAL & PLASTIC SURGERY
INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
ACCESSORY, SURGICAL APPAREL
Establishment Types
Export Device to the United States But Perform No Other Operation on Device