FDA Registration
Active
🇩🇪 Germany
EASY logO
Reg #: 3010948104
·
FEI: 3010948104
·
Expires 2025
Products
1
Proprietary Names
4
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- RECO MEDIZINTECHNIK WOLFGANG RENTSCH EK
- Registration Number
- 3010948104
- FEI Number
- 3010948104
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Altjessen 2
- City
- Pirna Saxony
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K130529
Owner / Operator
- Firm Name
- RECO MEDIZINTECHNIK Wolfgang Rentsch eK
- Operator Number
- 10046868
- Address
- Altjessen 2
- City
- Pirna
- State
- Saxony
- Postal Code
- D-01796
- Country
- DE
- Correspondent
- Wolfgang H Rentsch
US Agent
- Business Name
- RAUMEDIC Inc.
- Contact Name
- Jeremy Smith
- Address
- 235 Broadpointe Dr
- City
- Mills River
- State
- NC
- ZIP
- 28759
- Country
- US
- [email protected]
- Phone
- 828 4903262
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Device, Monitoring, Intracranial Pressure | GWM | Class 2 | Neurology | No | 2014-05-23 |
Proprietary Names
EASY logO
Main power adapter EASY logO
Stand Holder DATALOGGER
Table Stand DATALOGGER
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)