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Single-use Cystoscope
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref CY-M50Model CY-M52,CY-M50,CY-M40,CY-M32,CY-M52H,CY-M40H
Identity
- Trade Name
- Single-Use Cystoscope FDA UDI
- Generic Name
- Flexible video cystoscope, single-use FDA UDI
- Device Name
- Single-use Cystoscope EUDAMED
- Model / Reference
- CY-M52,CY-M50,CY-M40,CY-M32,CY-M52H,CY-M40H EUDAMEDCY-M50 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06970462541059 EUDAMED06970462546245 FDA UDI
- Basic UDI-DI
- 69704625420177U EUDAMED
- 510(k) Number
- K231118 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
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Single-use Cystoscope by Shenzhen HugeMed Medical Technical Development 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 | 69704625420177U | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- EUDAMED SRN
- CN-MF-000010895
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED 3cfe5b84-4c0b-45bf-9f6f-9c6f51bc985b 61 fields · synced May 31, 2026
- FDA UDI 4772c062-0329-42c3-abeb-1fa9bc6877eb 33 fields · synced May 30, 2026