FDA Registration
Inactive
🇨🇳 China
High Intensity Focused Ultrasound System:OM18,OM32 ,OMD04,OMF71,OME72,OM121,OM120,OM140,OMG77,OMG79,OMG108,
·
Expires 2025
Products
1
Proprietary Names
5
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- HEBEI MITA BIOTECHNOLOGY CO., LTD.
- Status
- Inactive
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- B-1008, Zhongchu Guangchang, 198hao Zhonghuabeidajie, Xinhuaqu,
- City
- Shijiazhuang Hebei
- Country
- CN
Owner / Operator
- Firm Name
- Hebei Mita Biotechnology Co., Ltd.
- Operator Number
- 10093706
- Address
- B-1008, Zhongchu Guangchang, 198hao Zhonghuabeidajie, Xinhuaqu,
- City
- Shijiazhuang
- State
- Hebei
- Postal Code
- 050061
- Country
- CN
- Correspondent
- Shujuan Zhao
US Agent
- Business Name
- REPF America LLC
- Contact Name
- Wilson Li
- Address
- 6510 S Academy Blvd
- City
- Co Spgs
- State
- CO
- ZIP
- 80916
- Country
- US
- [email protected]
- Phone
- 719 2013315
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2025-06-25 |
Proprietary Names
High Intensity Focused Ultrasound System:OM18,OM32 ,OMD04,OMF71,OME72,OM121,OM120,OM140,OMG77,OMG79,OMG108,
HF007,HF008,HF0023,HF009,HF0010,HF0011,HF0012,HF0013,HF0014,OMG135,HF0016,HF0018,HF0019,HF0020,HF0024,HF0025,AGF65,
OMG219,HF001,HF002,HF003,HF004,HF005,OMG193,HF006,HF0022,HF0017,HF0021,HF0026,
HF0028,HF0029,HF0031,HF0032,HF0033,HF0034,HF0035,HF0036,HF0037,HF0038,HF0039,HF0040,HF0041,HF0042,HF0043
OMG114,OMG131,OMG165,OMG210,OMG166,OMG167,OMG177,OMG191,OMG206,HF0030,OMG207,OMG199,OMG198,OMG211,OMG217,
Establishment Types
Manufacture Medical Device