FDA Registration
Active
🇲🇾 Malaysia
Dexcom10877 (BK, KK) - Dexcom G7 Continuous Glucose Sensing System
Reg #: 3038285067
·
FEI: 3038285067
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Synergy Sterilisation Kulim (M) Sdn. Bhd
- Registration Number
- 3038285067
- FEI Number
- 3038285067
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Plot 329F, Jalan Cassia Selatan 6/4,Kawasan Perindustrian Batu Kawan, Kawasan Perindustrian Batu Kawan
- City
- Seberang Perai Selatan Pulau Pinang
- Country
- MY
Regulatory Submissions
- 510(k) Number
- K213919
Owner / Operator
- Firm Name
- STERIS Corporation
- Operator Number
- 10042227
- Address
- 5960 Heisley Road
- City
- Mentor
- State
- OH
- Postal Code
- 44060
- Country
- US
US Agent
- Business Name
- STERIS CORPORATION
- Contact Name
- Becky Aldhizer
- Address
- 5960 Heisley Road
- City
- Mentor
- State
- OH
- ZIP
- 44060
- Country
- US
- [email protected]
- Phone
- 440 3927490
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Integrated Continuous Glucose Monitoring System, Factory Calibrated | QBJ | Class 2 | Clinical Chemistry | No | 2023-09-07 |
Proprietary Names
Dexcom10877 (BK, KK) - Dexcom G7 Continuous Glucose Sensing System
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)