FDA Registration
Active
🇨🇳 China
NeoNatalie Resuscitator
Reg #: 3004993040
·
FEI: 3004993040
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- LAERDAL MEDICAL (SUZHOU) CO., LTD.
- Registration Number
- 3004993040
- FEI Number
- 3004993040
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- NO.19 BLDG., HUOJU RD., SCIENCE & TECHNOLOGY IND. PARK
- City
- 215009 SUZHOU JIANGSU PROVINCE
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K132172
Owner / Operator
- Firm Name
- LAERDAL MEDICAL A/S
- Operator Number
- 9038993
- Address
- Tanke Svilandsgate 30, --
- City
- Stavanger
- State
- Rogaland
- Postal Code
- 4007
- Country
- NO
US Agent
- Business Name
- Laerdal Medical Corporation
- Contact Name
- Gina Beshai
- Address
- 167 MYERS CORNERS RD., --
- City
- Wappingers Falls
- State
- NY
- ZIP
- 12590
- Country
- US
- [email protected]
- Phone
- 845 6853187
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Ventilator, Emergency, Manual (Resuscitator) | BTM | Class 2 | Anesthesiology | No | 2015-04-15 |
Proprietary Names
NeoNatalie Resuscitator
NeoNatalie Complete Kit
Establishment Types
Manufacture Medical Device