FDA Registration
Active
🇳🇱 Netherlands
L-Mesitran Soft
Reg #: 3007582648
·
FEI: 3007582648
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- THEO MANUFACTURING BV
- Registration Number
- 3007582648
- FEI Number
- 3007582648
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Sleperweg 44
- City
- Maastricht Limburg
- Country
- NL
Regulatory Submissions
- 510(k) Number
- K150676
Owner / Operator
- Firm Name
- THEO MANUFACTURING BV
- Operator Number
- 10028046
- Address
- Sleperweg 44
- City
- Maastricht
- State
- Limburg
- Postal Code
- 6222 NK
- Country
- NL
- Correspondent
- Josephus Postmes
US Agent
- Business Name
- Sion Brands, LLC
- Contact Name
- Sandra Baldenegro
- Address
- 1214 Beltway Parkway
- City
- Laredo
- State
- TX
- ZIP
- 78045
- Country
- US
- [email protected]
- Phone
- 956 2206832
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Dressing, Wound, Drug | FRO | Class U | Unknown | No | 2016-01-20 |
Proprietary Names
L-Mesitran Soft
L-Mesitran Tulle
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Repack or Relabel Medical Device
Manufacture Medical Device