FDA Registration
Active
🇿🇦 South Africa
SINAPI BIOMEDICAL (PTY) LTD
Reg #: 3008388005
·
FEI: 3008388005
·
Expires 2026
Products
5
Proprietary Names
3
Establishment Types
3
Classifications
5
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Registration Details
- Registration Name
- SINAPI BIOMEDICAL (PTY) LTD
- Registration Number
- 3008388005
- FEI Number
- 3008388005
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- ARC-Infruitec North Campus, Lelie Road
- City
- Stellenbosch Western Cape
- Country
- ZA
Owner / Operator
- Firm Name
- Sinapi Biomedical (PTY) LTD
- Operator Number
- 10032397
- Address
- ARC-Infruitec North Campus, Lelie Road
- City
- Stellenbosch
- State
- ZA-NOTA
- Postal Code
- 7600
- Country
- ZA
- Correspondent
- Chris De Villiers
US Agent
- Business Name
- Myco Medical Supplies, Inc.
- Contact Name
- Sanjiv Kumar
- Address
- 2015 Production Drive
- City
- Apex
- State
- NC
- ZIP
- 27539
- Country
- US
- [email protected]
- Phone
- 800 4546926
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Blade, Scalpel | GES | Class 1 | General, Plastic Surgery | No | 2013-01-15 |
| Device, Urine Flow Rate Measuring, Non-Electrical, Disposable | FFG | Class 2 | Gastroenterology, Urology | No | 2010-10-15 |
| Handle, Scalpel | GDZ | Class 1 | General, Plastic Surgery | No | 2014-02-12 |
| Razor, Surgical | LWK | Class 1 | General, Plastic Surgery | No | 2022-12-08 |
| Bottle, Collection, Vacuum | KDQ | Class 2 | General Hospital | No | 2010-05-10 |
Proprietary Names
SINAPI Urine Meter
Sinapi Chest Drain
Sinapi LEVO
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device