FDA Registration
Active
🇨🇳 China
Shanghai Xodus Medical Company Limited
Reg #: 3010380518
·
FEI: 3010380518
·
Expires 2026
Products
25
Proprietary Names
26
Establishment Types
2
Classifications
25
Registration Details
- Registration Name
- Shanghai Xodus Medical Company Limited
- Registration Number
- 3010380518
- FEI Number
- 3010380518
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No.376 Honglan Road; 2nd Floor; Building 2, Hongmiao Industrial Zone; Fengxian District
- City
- Shanghai
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K260903
Owner / Operator
- Firm Name
- Xodus Medical Shanghai
- Operator Number
- 10043833
- Address
- No. 376 Honglan Rd. 2nd Floor Building 2, Hongmiao Industrial Zone, Fengxian Dist
- City
- Shanghai
- State
- CN-SH
- Postal Code
- 201411
- Country
- CN
- Correspondent
- Chen Ye
US Agent
- Business Name
- Xodus Medical
- Contact Name
- Paul Lloyd
- Address
- 702 Prominence Dr
- 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 |
|---|---|---|---|---|---|
| Non-Surgical Gown | OEA | Class 1 | General, Plastic Surgery | No | 2020-04-10 |
| Marker, Skin | FZZ | Class 1 | General, Plastic Surgery | No | 2013-03-27 |
| Support, Patient Position | CCX | Class 1 | Anesthesiology | No | 2013-03-27 |
| System, Thermal Regulating | DWJ | Class 2 | Cardiovascular | No | 2026-04-21 |
| Handle, Scalpel | GDZ | Class 1 | General, Plastic Surgery | No | 2013-03-27 |
| Gauze/Sponge, Internal, X-Ray Detectable | GDY | Class 1 | General, Plastic Surgery | No | 2013-03-27 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2021-02-04 |
| Tape, Measuring, Rulers And Calipers | FTY | Class 1 | General, Plastic Surgery | No | 2017-11-04 |
| Basin, Emesis | FNY | Class 1 | General Hospital | No | 2013-03-27 |
| Fiber, Medical, Absorbent | FRL | Class 1 | General Hospital | No | 2013-03-27 |
| Syringe, Irrigating (Non Dental) | KYZ | Class 1 | General Hospital | No | 2013-03-27 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2019-10-28 |
| Anti Fog Solution And Accessories, Endoscopy | OCT | Class 2 | Gastroenterology, Urology | No | 2019-10-28 |
| Catheter And Tip, Suction | JOL | Class 2 | General Hospital | No | 2013-03-27 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2013-03-27 |
| Device, Transfer, Patient, Manual | FMR | Class 1 | General Hospital | No | 2023-02-22 |
| Operating Room Accessories Table Tray | FWZ | Class 1 | General, Plastic Surgery | No | 2013-03-27 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2020-04-10 |
| Light, Surgical, Accessories | FTA | Class 2 | General, Plastic Surgery | No | 2013-03-27 |
| Needle, Suturing, Disposable | GAB | Class 1 | General, Plastic Surgery | No | 2013-03-27 |
| Container, Liquid Medication, Graduated | KYW | Class 1 | General Hospital | No | 2013-03-27 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2013-03-27 |
| Kit, Surgical Instrument, Disposable | KDD | Class 1 | General, Plastic Surgery | No | 2017-11-02 |
| Component, Traction, Non-Invasive | KQZ | Class 1 | Orthopedic | No | 2013-03-27 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2013-03-27 |
Proprietary Names
Isolation Gown
Skin Marker
Foam Positioning
Hot Pink Pad Controller
Hot Pink Pad
Scalpel Handle
Sponges
Grounding Pad
Ruler
Emesis Bag
Absorbent Mat, Mop Heads
Syringe, Bulb Syringe, Asepto syringe
See Sharp, Trocar Swab
Suction Tips
Bandage
Air Transfer Mattress, Blower Motor
Tray
Face Protection Shield
Light Handle Cover
Needle Counter, Plastic Cup, Plastic Box
Cup
ES Pencil and Tips
Tray Corner Protector, Suture Bag, Nasotracheal Tube Immobilizer
Room Turnover Kit
Shoulder kit
Saf-T Pass, Transfer Zone, Plastic Holder
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device