FDA Registration
Active
🇺🇸 United States
Durex Classic
Reg #: 3011015568
·
FEI: 3011015568
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- RB Health (US) LLC
- Registration Number
- 3011015568
- FEI Number
- 3011015568
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 399 Interpace Parkway
- City
- Parsippany
- State
- NJ
- ZIP
- 07054
- Country
- US
Regulatory Submissions
- 510(k) Number
- K113061
Owner / Operator
- Firm Name
- RB Health (US) LLC
- Operator Number
- 9004884
- Address
- 399 Interpace Parkway
- City
- Parsippany
- State
- NJ
- Postal Code
- 07054
- Country
- US
- Correspondent
- Andrew - Alum
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Condom | HIS | Class 2 | Obstetrics/Gynecology | No | 2015-11-03 |
Proprietary Names
Durex Classic
Establishment Types
Complaint File Establishment per 21 CFR 820.198