FDA Registration
Active
🇨🇳 China
HANGZHOU FORMED MEDICAL DEVICES CO., LTD.
Reg #: 3013412170
·
FEI: 3013412170
·
Expires 2026
Products
9
Proprietary Names
31
Establishment Types
4
Classifications
9
Registration Details
- Registration Name
- HANGZHOU FORMED MEDICAL DEVICES CO., LTD.
- Registration Number
- 3013412170
- FEI Number
- 3013412170
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Building 3, No. 292 Gonghe North Road, Xindeng Town, Fuyang District
- City
- Hangzhou Zhejiang
- Country
- CN
Owner / Operator
- Firm Name
- Hangzhou Formed Medical Devices Co., Ltd.
- Operator Number
- 10052858
- Address
- Building 3, No. 292 Gonghe North Road, Xindeng Town, Fuyang District
- City
- Hangzhou
- State
- Zhejiang
- Postal Code
- 311404
- Country
- CN
- Correspondent
- Guo Yongxuan
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 |
|---|---|---|---|---|---|
| Device, Fixation, Tracheal Tube | CBH | Class 1 | Anesthesiology | No | 2024-06-20 |
| Catheters, Suction, Tracheobronchial | BSY | Class 1 | Anesthesiology | No | 2024-06-20 |
| Catheter And Tip, Suction | JOL | Class 2 | General Hospital | No | 2024-06-20 |
| Cannula, Nasal, Oxygen | CAT | Class 1 | Anesthesiology | No | 2021-03-19 |
| Circuit, Breathing (W Connector, Adaptor, Y Piece) | CAI | Class 1 | Anesthesiology | No | 2016-10-13 |
| Airway, Oropharyngeal, Anesthesiology | CAE | Class 1 | Anesthesiology | No | 2016-10-13 |
| Stylet, Tracheal Tube | BSR | Class 1 | Anesthesiology | No | 2016-10-13 |
| Mask, Gas, Anesthetic | BSJ | Class 1 | Anesthesiology | No | 2022-05-09 |
| Airway, Nasopharyngeal | BTQ | Class 1 | Anesthesiology | No | 2021-03-20 |
Proprietary Names
Catheter Fixation Device
Endotracheal Tube Holder
Tracheostomy Tube Holder
Mucus Extractor
Suction Catheter
Closed Suction Catheter
Suction Tubing
Suction Tubing with Yankauer Handle
Yankauer Suction
Nasal Cannula
Silicone Nasal Cannula
Silicone Extension Cannula
Catheter Mount
Breathing Circuit
Anesthesia Breathing Circuit
Laryngeal Mask
Oral-pharyngeal Airway
Flexi 2G SAD Introducer
Laryngeal Mask Introducer
Guedel Airway
Laryngeal Mask W/Gastirc Access
Tracheal Tube Introducer
Intubating Stylet
Rigid Stylet
Introducer Bougie
Endotracheal tube Stylet
Anaesthetic Mask
Inflatable Anesthesia Mask
Silicone Anesthesia Mask
Silicone Mask
Nasopharyngeal Airway
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Repack or Relabel Medical Device