FDA Registration
Active
🇲🇾 Malaysia
KHTP STERILISATION SERVICES SDN. BHD.
Reg #: 3022518300
·
FEI: 3022518300
·
Expires 2026
Products
11
Proprietary Names
17
Establishment Types
1
Classifications
11
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Registration Details
- Registration Name
- KHTP STERILISATION SERVICES SDN. BHD.
- Registration Number
- 3022518300
- FEI Number
- 3022518300
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Lot 33, Jalan Hi-Tech 4
- City
- Kulim Hi Tech Park Kedah
- Country
- MY
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 |
|---|---|---|---|---|---|
| Stylet, Tracheal Tube | BSR | Class 1 | Anesthesiology | No | 2024-06-25 |
| Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | FOZ | Class 2 | General Hospital | No | 2025-07-15 |
| Catheter, Retention Type, Balloon | EZL | Class 2 | Gastroenterology, Urology | No | 2024-06-25 |
| Tube, Tracheal (W/Wo Connector) | BTR | Class 2 | Anesthesiology | No | 2024-06-25 |
| Catheter, Urethral | GBM | Class 2 | Gastroenterology, Urology | No | 2024-06-25 |
| Catheter, Urological | KOD | Class 2 | Gastroenterology, Urology | No | 2024-06-25 |
| Wound Dressing Kit | MCY | Class 2 | General Hospital | No | 2022-04-25 |
| Airway, Nasopharyngeal | BTQ | Class 1 | Anesthesiology | No | 2024-06-25 |
| Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) | FCM | Class 2 | Gastroenterology, Urology | No | 2024-06-25 |
| Introducer, Catheter | DYB | Class 2 | Cardiovascular | No | 2025-07-15 |
| Pump, Infusion, Elastomeric | MEB | Class 2 | General Hospital | No | 2023-08-18 |
Proprietary Names
Rusch Simplastic Foley Catheters
Standard Connector
RUSCH BRILLANT SILICONE FOLEY
(Rusch FloCath Quick, Rusch FloCath Quick Kit, Rusch FloCath Intermittent Catheter
Rusch Hydrophilic Intermittent catheters
Rusch MMG H2O PVC Catheter Kit, Rusch MMG H2O Singles)
Tracheal Tube
Teleflex
Oral/Nasal Safety Clear Trache tube cuffed, magill/murphy
SLICK SET
RUSCH MMG/O'NEIL CATHETER
Rusch Silicone Foley Catheter
Multiple Tracheal Tubes W/O Connect
Rusch MMG H2O PVC Catheter Kit, Rusch MMG H2O Singles
Rusch FloCath Quick, Rusch FloCath Quick Kit, Rusch FloCath Intermittent Catheter
AGT PVC Preform Oral trachea tube cuffed w/mur eye
AGT PVC Preform Nasal trachea tube uncuff w/ mur eye
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)