FDA Registration
Active
🇩🇪 Germany
TeWa acupuncture needles
Reg #: 9614607
·
FEI: 3003191258
·
Expires 2025
Products
1
Proprietary Names
16
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ASIA-MED GMBH
- Registration Number
- 9614607
- FEI Number
- 3003191258
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Kirchplatz 1
- City
- Pullach i.I. Bavaria
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K132896
Owner / Operator
- Firm Name
- ASIA-MED GMBH
- Operator Number
- 9043114
- Address
- Kirchplatz 1, --
- City
- Pullach
- State
- DE-NOTA
- Postal Code
- 82049
- Country
- DE
- Correspondent
- CHRISTIAN - STICHWEH
US Agent
- Business Name
- REGULATORY INSIGHT, INC.
- Contact Name
- KEVIN WALLS
- Address
- 33 Golden Eagle Lane
- City
- Littleton
- State
- CO
- ZIP
- 80127
- Country
- US
- [email protected]
- Phone
- 720 9625412
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Needle, Acupuncture, Single Use | MQX | Class 2 | General Hospital | No | 2014-01-29 |
Proprietary Names
TeWa acupuncture needles
TeWa KB-Type
TeWa DPB-Type
TeWa 5KB-Type
TeWa 5CB-Type
TeWa CJ-Type Safe-T Sleeve
TeWa PB-Type
TeWa 10KB-Type
TeWa 5JB-Type
TeWa JJ-Type
TeWa PJ-Type
TeWa JB-Type
TeWa KJ-Type
TeWa CJ-Type
TeWa CB-Type
TeWa ID-Type
Establishment Types
Export Device to the United States But Perform No Other Operation on Device