FDA Registration
Active
🇨🇳 China
PRO-MED (WUXI)IMP.& EXP.CO.,LTD.
Reg #: 3012002722
·
FEI: 3012002722
·
Expires 2026
Products
24
Proprietary Names
32
Establishment Types
1
Classifications
24
Registration Details
- Registration Name
- PRO-MED (WUXI)IMP.& EXP.CO.,LTD.
- Registration Number
- 3012002722
- FEI Number
- 3012002722
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No.282 Changjiang North Rd, Xinwu District,
- City
- Wuxi Jiangsu
- Country
- CN
Owner / Operator
- Firm Name
- Pro-Med (Wuxi)Imp.& Exp.Co.,Ltd.
- Operator Number
- 10085601
- Address
- No.282 Changjiang North Rd, Xinwu District,
- City
- Wuxi
- State
- Jiangsu
- Postal Code
- 214000
- Country
- CN
- Correspondent
- Yong an Zhao
US Agent
- Business Name
- Regrek LLC
- Contact Name
- Leeyeo Kee
- Address
- 19 Holly Cove Ln.
- City
- Dover
- State
- DE
- ZIP
- 19901
- Country
- US
- [email protected]
- Phone
- 302 6089028
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Bag, Drainage, With Adhesive, Ostomy | FON | Class 1 | Gastroenterology, Urology | No | 2025-12-16 |
| Airway, Oropharyngeal, Anesthesiology | CAE | Class 1 | Anesthesiology | No | 2022-07-08 |
| Marker, Skin | FZZ | Class 1 | General, Plastic Surgery | No | 2023-12-20 |
| Bandage, Elastic | FQM | Class 1 | General Hospital | No | 2022-07-08 |
| Blade, Scalpel | GES | Class 1 | General, Plastic Surgery | No | 2022-07-08 |
| Gauze / Sponge,Nonresorbable For External Use | NAB | Class 1 | General, Plastic Surgery | No | 2024-12-13 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2022-07-08 |
| Enema Kit | FCE | Class 1 | Gastroenterology, Urology | No | 2025-12-16 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2022-07-08 |
| Nebulizer, Medicinal, Non-Ventilatory (Atomizer) | CCQ | Class 1 | Anesthesiology | No | 2023-12-20 |
| Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua | QKR | Class N | Unknown | No | 2022-07-08 |
| Condenser, Heat And Moisture (Artificial Nose) | BYD | Class 1 | Anesthesiology | No | 2022-07-08 |
| Syringe, Irrigating (Non Dental) | KYZ | Class 1 | General Hospital | No | 2022-07-08 |
| Catheter, Nasal, Oxygen | BZB | Class 1 | Anesthesiology | No | 2022-07-08 |
| Catheter, Infusion | JCY | Class 1 | General, Plastic Surgery | No | 2022-07-08 |
| Mouthpiece, Breathing | BYP | Class 1 | Anesthesiology | No | 2024-12-13 |
| Cylinder, Compressed Gas, And Valve | ECX | Class 1 | Anesthesiology | No | 2023-12-20 |
| Device, Rebreathing | BYW | Class 1 | Anesthesiology | No | 2025-12-16 |
| Tray, Surgical, Ent | MMO | Class 1 | Ear, Nose, Throat | No | 2023-12-20 |
| Pump, Nebulizer, Manual | EPN | Class 1 | Ear, Nose, Throat | No | 2023-12-20 |
| Mask, Oxygen | BYG | Class 1 | Anesthesiology | No | 2022-07-08 |
| Mask, Gas, Anesthetic | BSJ | Class 1 | Anesthesiology | No | 2022-07-08 |
| Tube, Aspirating, Flexible, Connecting | BYY | Class 2 | General Hospital | No | 2024-12-13 |
| Laryngoscope, Rigid | CCW | Class 1 | Anesthesiology | No | 2023-12-20 |
Proprietary Names
Bag, Drainage, With Adhesive, Drainage Bag, Ostomy bags
Airway, Oropharyngeal, Anesthesiology-Disposable PVC/Reinforced PVC Laryngeal Mask Airway,
Disposable /Reusable Silicone Laryngeal Mask Airway
Identification bracelets
Bandage, Elastic-Adhesive Elastic Bandage, Cotton Elastic Bandage, Crepe Bandage, Elastic Bandage Bandage
Blade, Scalpel-Surgical Blades, Surgical Blades with Plastic Handle
Gauze /Sponge, Non resorbable For External Use - Abdominal Pads; Gauze Bandages; Gauze Compresses; Gauze Rolls;
Compressed sponge sheet, Spong stick (swab), Nylon brush scrub clean brush, cotton applicator, surgical drape,
lap sponge, cast padding
Gauze Sponges; Medical Gauze, Gauze roll, Gauze piece, Gauze pad, Gauze bandage Sponge brush, Surgical Scrub brush,
Tape and Bandage, Adhesive-Adhesive Elastic Bandage, Non-Woven Tape, PE Tape, Silk Tape, Zinc Oxide Adhesive Plaster
Enema Kit Feeding bag, Enteral Feeding bag, Enteral Feeding set, Enfit syringe, Feeding Tube
Accessory, Surgical Apparel - Nurse Bouffant Cap, Patient`s Gowns, Pillow Case, Shoes Cover, Surgeon Cap
Nebulizer
Face Mask
Condenser. Heat And Moisture (Artificial Nose)- HMEs-Heat and Moisture Exchange Filters, HME For Tracheostomy Patient
Syringe, Irrigating (Non-Dental) -Disposable Syringes, General Hospital syringe
Cannula, Nasal, Oxygen-Nasal Cannula
Catheter, Infusion-Catheter for Infusion, Extension Tube
Silicone/SEBS/PVC Manual Resuscitators (Oxygen Tube)
Silicone/SEBS/PVC Manual Resuscitators (Reservoir); Silicone/SEBS/PVC Manual Resuscitators (Mask);
Regulator, Pressure, Gas Cylinder
Device, Rebreathing ARI Medical Oxygen Concentrator, Spirometer, Deivce, Rebreathing-CPR Cushion, Rebreathing Device,
Breathing Exerciser
Tray, Kidney Dish, Surgical, Instrument - Mayo Sand
Nebulizer compressors
Mask, Oxygen -Oxygen Mask, Rebreathing and Non-Rebreathing, Tracheostomy Mask, Aerosol Mask,
Continuous Positive Airway Pressure Mask, Nasal Oxygen Cannulas, Oxygen Tubing, CO2 Samping Cannule
Mask, Gas, Anesthetic-Disposable Air Cushion Face Mask, CPR Mask, CPAP Mask
Suction connecting tube with Yankauer handle, Connecting Tube, Infiltration Tubing
Tube, aspirating, flexible, connecting, Yankauer handle, Connecting Tube with Yankauer Handle,
LARYNGOSCOPE, NON-RIGID; laryngoscope, rigid video laryngoscope
Establishment Types
Export Device to the United States But Perform No Other Operation on Device