FDA Registration
Active
🇨🇳 China
Zhejiang Medtec Medical devices Co., Ltd
Reg #: 3007649127
·
FEI: 3007649127
·
Expires 2026
Products
10
Proprietary Names
49
Establishment Types
1
Classifications
10
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Registration Details
- Registration Name
- Zhejiang Medtec Medical devices Co., Ltd
- Registration Number
- 3007649127
- FEI Number
- 3007649127
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No 77 Yangdai Rd, Linan Hangzhou
- City
- Hangzhou Zhejiang
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K120424
Owner / Operator
- Firm Name
- Zhejiang Medtec Medical devices Co., Ltd
- Operator Number
- 10028750
- Address
- No 77 Yangdai Rd, Linan Hangzhou
- City
- Hangzhou
- State
- Zhejiang
- Postal Code
- 311301
- Country
- CN
US Agent
- Business Name
- MedSource International, LLC.
- Contact Name
- Emilie Andrews
- Address
- 8600 Shelby Court
- City
- Chanhassen
- State
- MN
- ZIP
- 55317
- Country
- US
- [email protected]
- Phone
- 952 4720131
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Nebulizer, Medicinal, Non-Ventilatory (Atomizer) | CCQ | Class 1 | Anesthesiology | No | 2009-03-03 |
| Set, I.V. Fluid Transfer | LHI | Class 2 | General Hospital | No | 2013-01-02 |
| Mask, Oxygen, Non-Rebreathing | KGB | Class 1 | Anesthesiology | No | 2009-03-03 |
| Apparatus, Suction, Operating-Room, Wall Vacuum Powered | GCX | Class 2 | General Hospital | No | 2009-03-03 |
| Mouthpiece, Breathing | BYP | Class 1 | Anesthesiology | No | 2026-03-16 |
| Catheter, Nasal, Oxygen | BZB | Class 1 | Anesthesiology | No | 2010-12-16 |
| Mask, Oxygen | BYG | Class 1 | Anesthesiology | No | 2012-08-27 |
| Cannula, Nasal, Oxygen | CAT | Class 1 | Anesthesiology | No | 2009-03-03 |
| Mask, Gas, Anesthetic | BSJ | Class 1 | Anesthesiology | No | 2020-04-14 |
| Catheters, Suction, Tracheobronchial | BSY | Class 1 | Anesthesiology | No | 2009-03-03 |
Proprietary Names
Nebulizer without mask
Nebulizer with mask
Nebulizer hand held
MedSource I.V. Administration Set
High Concentrate NRB Mask
Non-Rebreather with vent
Tee Aerosol
Mask, Oxygen
Curaplex Total Non-Rebreather
Mask Oxygen nonrebreather
Mask Oxygen, Nonrebreather
Non-Rebreather, w/ Univ. Conn
Non-Rebreather
Yankaeur Tip & Tube, Non-Vented
Yankaeur Tip only, Vented
Yankaeur Tube only
Yankaeur Tip & Tube, Vented
Yankaeur Tube only, Vented
Yankaeur Tip only, Non-Vented
CPR barrier
Catheter
Oxygen Mask Elongated
Aerosol Mask under chin
Trah Mask Kit All Diluters, U Conn
Tracheostomy Mask No tubing
Oxygen Mask
Aerosol Mask Elongated
Venturi Mask Kit All Diluters
Aerosol Mask Under Lip No Tubing
Oxygen Mask U. Conn.
Nasal Cannula Tubing
Oxygen Delivery Kit
Nasal Cannula
Adaptor Universal
Oxygen nasal Cannula
Soft Cannula
Nasal Cannula curved prong
Soft Cannula Univ. Conn.
Cannula Nonflared
Nasal Cannula Flared
Connecting Tubing
Soft Cannula tubing
Nasal Cannula univ. Conn.
Cannula Flared
Nasal Cannula Nonflared
Anesthetic Mask
Suction Catheter
Manual Section Pump refill Cannister
Manual Suction Pump
Establishment Types
Manufacture Medical Device