FDA Registration
Active
🇮🇱 Israel
Gerium Medical Ltd
Reg #: 3042972073
·
FEI: 3042972073
·
Expires 2026
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
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Registration Details
- Registration Name
- Gerium Medical Ltd
- Registration Number
- 3042972073
- FEI Number
- 3042972073
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 4 Paran St., Building 11, Yavne, Israel.
- City
- Yavne Central
- Country
- IL
Regulatory Submissions
- 510(k) Number
- K243372
Owner / Operator
- Firm Name
- Gerium
- Operator Number
- 10094882
- Address
- P.O Box 13271, 4 Paran St., Building 11, Yavne, Israel.
- City
- Yavne
- State
- Central
- Postal Code
- 8122503
- Country
- IL
- Correspondent
- Noam Rubin Tal
US Agent
- Business Name
- SUNG KWON
- Contact Name
- Tiffany Shin
- Address
- 13925 City Center Dr Ste 200
- City
- Chino Hills
- State
- CA
- ZIP
- 91709
- Country
- US
- [email protected]
- Phone
- 909 4933276
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Unit, Neonatal Phototherapy | LBI | Class 2 | General Hospital | No | 2026-01-14 |
Proprietary Names
BiliWrap Phototherapy System
Establishment Types
Manufacture Medical Device