FDA Registration
Active
🇨🇳 China
HENAN TUOREN MEDICAL DEVICE CO., LTD.
Reg #: 3006984712
·
FEI: 3006984712
·
Expires 2026
Products
5
Proprietary Names
7
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- HENAN TUOREN MEDICAL DEVICE CO., LTD.
- Registration Number
- 3006984712
- FEI Number
- 3006984712
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Weiyuan Industrial Zone, Menggang, Changyuan, 453400 Henan, CHINA, Middle of Weft 7 Road, Nanpu District, Changyuan, 453400 Henan, CHINA
- City
- Changyuan Henan
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K152251
Owner / Operator
- Firm Name
- Henan Tuoren Medical Device Co., Ltd.
- Operator Number
- 10025262
- Address
- Weiyuan Industrial Zone, Menggang, Middle of Weft 7 Road, Nanpu District
- City
- Xinxiang
- State
- Henan
- Postal Code
- 453400
- Country
- CN
- Correspondent
- GuoSheng Wang
US Agent
- Business Name
- Global quality consultants
- Contact Name
- Stephen Lieberman
- Address
- 4545 N Ocean Blvd., Unit 11A
- City
- Boca Raton
- State
- FL
- ZIP
- 33431
- Country
- US
- [email protected]
- Phone
- 561 3020777
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector) | CBI | Class 2 | Anesthesiology | No | 2016-06-13 |
| Airway, Oropharyngeal, Anesthesiology | CAE | Class 1 | Anesthesiology | No | 2008-03-28 |
| Mask, Gas, Anesthetic | BSJ | Class 1 | Anesthesiology | No | 2008-03-28 |
| Circuit, Breathing (W Connector, Adaptor, Y Piece) | CAI | Class 1 | Anesthesiology | No | 2008-03-28 |
| Condenser, Heat And Moisture (Artificial Nose) | BYD | Class 1 | Anesthesiology | No | 2014-05-12 |
Proprietary Names
Tuoren Double-lumen Endotracheal Tube
Blockbuster Laryngeal Mask Airway (Model: 1#,1.5#,2#, 2.5#, 3#, 4#, 5#)
Oropharyngeal airway (Model: 4#, 5#, 6#, 7#, 8#, 9#, 10#, 11#, 12#, 3cm~12cm)
Medical Laryngeal Mask Airway (Model: 1#,1.5#,2#, 2.5#, 3#, 4#, 5#)
Anesthetic Mask(Bending edge model: 0#,1#,2#,3#,4#,5#; Detachable model: 3#,4#,5#; Inflatalbe model:0#,1#,2#,3#,4#,5#)
Breathing Circuit
Heat and Moisture Exchanger (Specifications: Adult/Child/infant/Tracheotomy)
Establishment Types
Manufacture Medical Device