Identity
- Trade Name
- Single-Use Flexible Cystoscope FDA UDI
- Generic Name
- Flexible video cystoscope, single-use FDA UDI
- Device Name
- Single-use Flexible Cystoscope EUDAMED
- Model / Reference
- CY-E2F01R EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06972197483536 EUDAMED06972197483161 FDA UDI
- Basic UDI-DI
- 697219748CY4E EUDAMED
- 510(k) Number
- K242535 FDA UDI
- FDA Product Code
- FAJ FDA UDI
- EMDN Code
- Z12020701 CYSTOSCOPES EUDAMED
- GMDN Term
- Flexible video cystoscope, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Single-use Flexible Cystoscope by Hunan Vathin Medical Instrument Co., Ltd. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697219748CY4E | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Hunan Vathin Medical Instrument Co., Ltd.
- EUDAMED SRN
- CN-MF-000002593
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (2)
- EUDAMED 88bc5bd7-83ce-4a08-9a1a-7f5256694ab4 61 fields · synced May 31, 2026
- FDA UDI cfdc8c85-8466-4399-9766-659b1ca5b6a3 33 fields · synced May 29, 2026