FDA Registration
Active
🇨🇳 China
Video Laryngoscope Accessory-Handle (NEO-0/NEO-1)
Reg #: 3013528571
·
FEI: 3013528571
·
Expires 2025
Products
1
Proprietary Names
13
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- SHENZHEN INSIGHTERS MEDICAL TECHNOLOGY CO., LTD.
- Registration Number
- 3013528571
- FEI Number
- 3013528571
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Floor 13th, HTM Building, Ganli Road, Longgang District
- City
- Shenzhen Guangdong
- Country
- CN
Owner / Operator
- Firm Name
- Shenzhen Insighters Medical Technology Co., Ltd.
- Operator Number
- 10053495
- Address
- The 13th floor of Hengtemei Building,Ganli Road No. 3
- City
- Shenzhen
- State
- Guangdong
- Postal Code
- 518000
- Country
- CN
- Correspondent
- Xiao Hua
US Agent
- Business Name
- IRC USA
- Contact Name
- Charles Mack
- Address
- 2950 E Lindrick Dr
- City
- Chandler
- State
- AZ
- ZIP
- 85249
- Country
- US
- [email protected]
- Phone
- 931 6254938
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Laryngoscope, Rigid | CCW | Class 1 | Anesthesiology | No | 2016-12-09 |
Proprietary Names
Video Laryngoscope Accessory-Handle (NEO-0/NEO-1)
Single-Use Laryngoscope Blade,Model: MAC1 SS;MAC2 S;MAC3 M;MAC4 L;SS-Pro;S-Pro;M-Pro;L-Pro;MAC3;MAC4
Video Laryngoscope,Model: iS3-L
Video Rigid Laryngoscope, Model: iS3-R
Video Laryngoscope, Model: insight iS6
Video Laryngoscope, Model: insight iS2
Video Laryngoscope Accessory-Handle (iS6-H)
Video Laryngoscope Accessory-Handle (iS3)
Video Laryngoscope Accessory- 3.5 inch Host (iS3)
Video Laryngoscope Accessory-Power Adapter
Video Laryngoscop Accessory-3.5 inch Host (iS6-M)
Single-Use Laryngoscope Blade,Model: i6-SS;i6-S;i6-M;i6-L;SS;S;M;L
Video Laryngoscope, Model: iS-NEO
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device