Identity
- Trade Name
- Single-Use Flexible Cystoscope FDA UDI
- Generic Name
- Flexible video cystoscope, single-use FDA UDI
- Model / Reference
- CY-S1D00R FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06972197483109 FDA UDI
- 510(k) Number
- K221580 FDA UDI
- FDA Product Code
- FAJ FDA UDI
- GMDN Term
- Flexible video cystoscope, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Flexible video cystoscope, single-use
Single-Use Flexible Cystoscope by Hunan Vathin Medical Instrument Co., Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K221580 also covers:
- Single-Use Flexible Cystoscope — Hunan Vathin Medical Instrument Co., Ltd
- Single-Use Flexible Cystoscope — Hunan Vathin Medical Instrument Co., Ltd
- Single-Use Flexible Cystoscope — Hunan Vathin Medical Instrument Co., Ltd
- Single-Use Flexible Cystoscope — Hunan Vathin Medical Instrument Co., Ltd
- Single-Use Flexible Cystoscope — Hunan Vathin Medical Instrument Co., Ltd
- Single-Use Flexible Cystoscope — Hunan Vathin Medical Instrument Co., Ltd
- Single-Use Flexible Cystoscope — Hunan Vathin Medical Instrument Co., Ltd
- Single-Use Flexible Cystoscope — Hunan Vathin Medical Instrument Co., Ltd
- Single-Use Flexible Cystoscope — Hunan Vathin Medical Instrument Co., Ltd
- Single-Use Flexible Cystoscope — Hunan Vathin Medical Instrument Co., Ltd
- Single-Use Flexible Cystoscope — Hunan Vathin Medical Instrument Co., Ltd
- Single-Use Flexible Cystoscope — Hunan Vathin Medical Instrument Co., Ltd
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Hunan Vathin Medical Instrument Co., Ltd
Sources (1)
- FDA UDI b43bc473-949c-468d-88dd-466afaaa2304 33 fields · synced May 30, 2026