FDA Registration
Active
🇩🇪 Germany
RSL 2100
Reg #: 3002439654
·
FEI: 3002439654
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- TOMEY GMBH
- Registration Number
- 3002439654
- FEI Number
- 3002439654
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Wiesbadener Str. 21
- City
- Nuremberg Bavaria
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K152429
Owner / Operator
- Firm Name
- Tomey GmbH
- Operator Number
- 10039238
- Address
- Wiesbadener Str. 21
- City
- Nuremberg
- State
- Bavaria
- Postal Code
- 90427
- Country
- DE
- Correspondent
- Zita von Glatz
US Agent
- Business Name
- BK frames CORP
- Contact Name
- Alejandro Kacheroff
- Address
- 8565 W 44TH AVE, UNIT 111
- City
- Hialeah
- State
- FL
- ZIP
- 33018
- Country
- US
- [email protected]
- Phone
- 305 6850001
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Biomicroscope, Slit-Lamp, Ac-Powered | HJO | Class 2 | Ophthalmic | No | 2019-04-10 |
Proprietary Names
RSL 2100
RSL 2600
RSL 2600digital
Establishment Types
Foreign Private Label Distributor