HSA · registration DE0510057SPY Cystoscope/Hysteroscope
SingaporeObstetrics & GynaecologyClass BStryker Endoscopy
Official record identity
- Registration number
- DE0510057
- Model name
- SPY® Cystoscope/Hysteroscope, Autoclavable, Speed-Lock™, 4mm x 0°, 30cm; SPY® Cystoscope/Hysteroscope, Autoclavable, Speed-Lock™, 4mm x 12°, 30cm; SPY® Cystoscope/Hysteroscope, Autoclavable, Speed-Lock™, 4mm x 30°, 30cm; SPY® Cystoscope/Hysteroscope, Autoclavable, Speed-Lock™, 4mm x 70°, 30cm; SPY® Cystoscope/Hysteroscope, Autoclavable, KS-Series, 4mm x 0°, 30cm; SPY® Cystoscope/Hysteroscope, Autoclavable, KS-Series, 4mm x 12°, 30cm; SPY® Cystoscope/Hysteroscope, Autoclavable, KS-Series, 4mm x 30°, 30cm; SPY® Cystoscope/Hysteroscope, Autoclavable, KS-Series, 4mm x 70°, 30cm
- Model identifier
- 0502-720-010; 0502-720-012; 0502-720-030; 0502-720-070; 0502-721-010; 0502-721-012; 0502-721-030; 0502-721-070
- Registration date
- November 20, 2024
Classification
- Risk class
- Class B
Official value: CLASS B
Published parties
- Product owner
- Stryker Endoscopy
- Registrant / registration holder
- STRYKER SINGAPORE PRIVATE LIMITED
Official description
The SPY Cystoscopes/Hysteroscopes are intended to provide visualization in general urological and gynecological surgery through the minimally invasive approach, by utilizing natural orifices to access the surgical site.
Additional source fields
- Product owner address
- 5900 Optical Court, San Jose, CA 95138, United States
- Registrant address
- 38 BEACH ROAD, #23-11, SOUTH BEACH TOWER, Singapore 189767
About this record
This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.