FDA Registration
Active
🇲🇾 Malaysia
Rusch MMG H2O PVC Catheter Kit, Rusch MMG H2O Singles
Reg #: 3022518300
·
FEI: 3022518300
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- KHTP STERILISATION SERVICES SDN. BHD.
- Registration Number
- 3022518300
- FEI Number
- 3022518300
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Lot 33, Jalan Hi-Tech 4
- City
- Kulim Hi Tech Park Kedah
- Country
- MY
Regulatory Submissions
- 510(k) Number
- K181979
Owner / Operator
- Firm Name
- Khtp Sterilisation Services Sdn. Bhd.
- Operator Number
- 10085005
- Address
- Lot 33, Jalan Hi-Tech 4
- City
- Kulim Hi Tech Park
- State
- Kedah
- Postal Code
- 09090
- Country
- MY
US Agent
- Business Name
- Registrar Corp
- Contact Name
- David Lennarz
- Address
- 144 Research Drive
- City
- Hampton
- State
- VA
- ZIP
- 23666
- Country
- US
- [email protected]
- Phone
- 757 2240177
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheter, Urological | KOD | Class 2 | Gastroenterology, Urology | No | 2024-06-25 |
Proprietary Names
Rusch MMG H2O PVC Catheter Kit, Rusch MMG H2O Singles
Rusch Hydrophilic Intermittent catheters
Rusch FloCath Quick, Rusch FloCath Quick Kit, Rusch FloCath Intermittent Catheter
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)