FDA Registration
Active
🇨🇳 China
Ispira Resuscitation System Circuit; NeoPIP Neonatal Resuscitation Kit; NeoPIP Resuscitation Circuit with PEEP
Reg #: 3006061749
·
FEI: 3006061749
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- FLEXICARE MEDICAL (DONGGUAN) LTD.
- Registration Number
- 3006061749
- FEI Number
- 3006061749
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- No. B-15 XICHENG INDUSTRIAL ZONE, HENGLI TOWN,
- City
- DONGGUAN CITY Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K103833
Owner / Operator
- Firm Name
- FLEXICARE MEDICAL LTD.
- Operator Number
- 8021995
- Address
- CYNON VALLEY BUSINESS PARK
- City
- MOUNTAIN ASH
- State
- Rhondda Cynon Taff
- Postal Code
- CF45 4ER
- Country
- GB
- Correspondent
- Khashayar - Poormand
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Attachment, Breathing, Positive End Expiratory Pressure | BYE | Class 2 | Anesthesiology | No | 2017-07-25 |
Proprietary Names
Ispira Resuscitation System Circuit; NeoPIP Neonatal Resuscitation Kit; NeoPIP Resuscitation Circuit with PEEP
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)