FDA Registration
Active
🇨🇳 China
SHAOXING UNDIS MEDICAL TECHNOLOGY COMPANY LIMITED
Reg #: 3011587055
·
FEI: 3011587055
·
Expires 2026
Products
17
Proprietary Names
18
Establishment Types
1
Classifications
17
Registration Details
- Registration Name
- SHAOXING UNDIS MEDICAL TECHNOLOGY COMPANY LIMITED
- Registration Number
- 3011587055
- FEI Number
- 3011587055
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No.12 Yuexing Technology Park, No.11 Fanrong Road, Binhai New Area, Innovation Park,No.398 Mahuan Road,
- City
- Shaoxing Zhejiang
- Country
- CN
Owner / Operator
- Firm Name
- SHAOXING UNDIS MEDICAL TECHNOLOGY COMPANY LIMITED
- Operator Number
- 10048510
- Address
- No. 12 Yuexing Technology Park, Fanrong Road, Binhai New Area, Shaoxing city,
- City
- Shaoxing
- State
- Zhejiang
- Postal Code
- 312366
- Country
- CN
- Correspondent
- XIAOJIAN ZENG
US Agent
- Business Name
- Richard B Kennedy
- Contact Name
- Richard B Kennedy
- Address
- 1 Pluckemin Way, Suite 101
- City
- Bedminster
- State
- NJ
- ZIP
- 07921
- Country
- US
- [email protected]
- Phone
- 973 2650766 ext. 222
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheters, Suction, Tracheobronchial | BSY | Class 1 | Anesthesiology | No | 2019-08-11 |
| System, Reading, Television, Closed-Circuit | HJG | Class 1 | Ophthalmic | No | 2015-01-21 |
| Condenser, Heat And Moisture (Artificial Nose) | BYD | Class 1 | Anesthesiology | No | 2017-03-31 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2020-03-22 |
| Connector, Catheter | GCD | Class 1 | General, Plastic Surgery | No | 2017-03-23 |
| Nebulizer, Medicinal, Non-Ventilatory (Atomizer) | CCQ | Class 1 | Anesthesiology | No | 2017-03-23 |
| Airway, Oropharyngeal, Anesthesiology | CAE | Class 1 | Anesthesiology | No | 2017-04-10 |
| Mask, Gas, Anesthetic | BSJ | Class 1 | Anesthesiology | No | 2015-01-21 |
| Mouthpiece, Breathing | BYP | Class 1 | Anesthesiology | No | 2021-07-26 |
| Mask, Oxygen | BYG | Class 1 | Anesthesiology | No | 2015-01-21 |
| Tubing, Pressure And Accessories | BYX | Class 1 | Anesthesiology | No | 2017-09-22 |
| Non-Surgical Gown | OEA | Class 1 | General, Plastic Surgery | No | 2020-03-22 |
| Bag, Reservoir | BTC | Class 1 | Anesthesiology | No | 2017-03-23 |
| Set, Tubing And Support, Ventilator (W Harness) | BZO | Class 1 | Anesthesiology | No | 2018-04-01 |
| Circuit, Breathing (W Connector, Adaptor, Y Piece) | CAI | Class 1 | Anesthesiology | No | 2015-01-21 |
| Clip, Nose | BXJ | Class 1 | Anesthesiology | No | 2021-07-26 |
| Cannula, Nasal, Oxygen | CAT | Class 1 | Anesthesiology | No | 2021-11-15 |
Proprietary Names
Catheter, Suction Catheter, Yankauer Suction Handle/Tubing, Closed Suction System
System, reading, television, closed-circuit
CONDENSER, HEAT AND MOISTURE (ARTIFICIAL NOSE)
ACCESSORY, SURGICAL APPAREL
CONNECTOR, CATHETER
Nebulizer, Nebulizer Mask, Nebulizer T-type, Nebulizer kit, Tracheostomy Mask Nebulizer
AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY
MASK, GAS, ANESTHETIC
Silicone/SEBS/PVC Manual Resuscitators
Manual Resuscitators(mask, PEEP valve, oxygen tube, reservoir bag, mouth opener, airway, Manometer)
Mask, Oxygen Mask, Oxygen Mask with CO2 Sampling Line, Non-rebreathing Oxygen Mask, Venturi Mask, Adjustable Venturi Mas
TUBING, PRESSURE AND ACCESSORIES
Non-surgical isolation gown
BAG, RESERVOIR
SET, TUBING AND SUPPORT, VENTILATOR (W HARNESS)
Circuit, breathing (w connector, adaptor, y piece)
CLIP, NOSE
Cannula, Nasal, Oxygen Cannula, Nasal Cannula, High Flow Nasal Cannula
Establishment Types
Manufacture Medical Device