FDA Registration
Active
🇨🇳 China
21544-3,PEDIATRIC GP PROBE MP00994
Reg #: 3010476117
·
FEI: 3010476117
·
Expires 2025
Products
1
Proprietary Names
14
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- BETACERA INC.
- Registration Number
- 3010476117
- FEI Number
- 3010476117
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- No. 1219 YunLi Road, WuJiang Development Zone
- City
- Suzhou City Jiangsu
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K121999
Owner / Operator
- Firm Name
- Betacera Inc.
- Operator Number
- 10048284
- Address
- No. 1219 YunLi Road, WuJiang Development Zone
- City
- Suzhou City
- State
- Jiangsu
- Postal Code
- 215200
- Country
- CN
- Correspondent
- Brown Koo
US Agent
- Business Name
- TE Connectivity
- Contact Name
- Meghna Patel
- Address
- 1740 Joe Bottle Blvd
- City
- El Paso
- State
- TX
- ZIP
- 79936
- Country
- US
- [email protected]
- Phone
- 980 2696234
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2016-11-08 |
Proprietary Names
21544-3,PEDIATRIC GP PROBE MP00994
20929,MU11228,DUAL,DISPOSABLE
SP21545, ADULT SKIN PROBE MP00995
21546,PEDIATRIC SKIN PROBE MP00997
21543, ADULT GP PROBE MP00991
21570, Neonatal Skin Probe MX-11001
"21547,MX-11000 PROBE,5/BAG (Disposable Skin Probe-Infant)"
21543-3,ADULT GP PROBE MP00992
Skin Probe, Draeger MU26036
Skin Probe, Draeger MU26035
21545-3, ADULT SKIN PROBE MP00996
21544, PEDIATRIC GP PROBE MP00993
20930,MU12551,PROBE,DUAL
21546-3,PEDIATRIC SKIN PROBE MP00998
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)