FDA Registration
Active
🇳🇱 Netherlands
171V400 miniMulti TEE Probe , supplied by Oldelft to Siemens (Siemens model V7M)
Reg #: 1000601180
·
FEI: 1000601180
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- OLDELFT B.V.
- Registration Number
- 1000601180
- FEI Number
- 1000601180
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Heertjeslaan 10
- City
- Delft Zuid-Holland
- Country
- NL
Regulatory Submissions
- 510(k) Number
- K132654
Owner / Operator
- Firm Name
- Oldelft B.V.
- Operator Number
- 10047391
- Address
- Heertjeslaan 10
- City
- Delft
- State
- Zuid-Holland
- Postal Code
- 2629 JG
- Country
- NL
- Correspondent
- Rob Smallenburg
US Agent
- Business Name
- Emergo Global Representation LLC
- Contact Name
- Yong Sun
- Address
- 2500 Bee Cave Rd., Bldg. 1, Ste. 300
- City
- Austin
- State
- TX
- ZIP
- 78746
- Country
- US
- [email protected]
- Phone
- 512 3279997
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Imaging, Pulsed Doppler, Ultrasonic | IYN | Class 2 | Radiology | No | 2014-08-21 |
| Catheter, Ultrasound, Intravascular | OBJ | Class 2 | Cardiovascular | No | 2014-08-21 |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | Class 2 | Radiology | No | 2014-08-21 |
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2014-08-21 |
Proprietary Names
171V400 miniMulti TEE Probe , supplied by Oldelft to Siemens (Siemens model V7M)
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)