Single-use Cystoscope
by Hunan Endoso Life Technology Co., Ltd United States EUDAMED
Ref PCS22-6Model PCS12-1, PCS12-2, PCS12-3, PCS22-1, PCS22-2, PCS22-3, PCS22-4, PCS22-5, PCS22-6, PCS24-1, PCS24-2, PCS24-3, PCS24-4, PCS24-5, PCS24-6
EMDN Z12020711
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number6124105CE01 | Date20 Apr 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Certificates
- 6124105CE01 Amended
Quality management system EU MDR
- Notified body
- Notified body 0344
- Issued
- 20 Apr 2026
- Expires
- 1 Nov 2029
- Reason
- Mnf ar change
Specification
- Device Name
- Single-use Cystoscope
- Model / Reference
- PCS12-1, PCS12-2, PCS12-3, PCS22-1, PCS22-2, PCS22-3, PCS22-4, PCS22-5, PCS22-6, PCS24-1, PCS24-2, PCS24-3, PCS24-4, PCS24-5, PCS24-6
- Primary DI / UDI-DI
- 06975202773417
- Basic UDI-DI
- 697520277YS020L5
- Direct Marketing DI
- 06975202773417
- EMDN Code
- Z12020711 Video cystourethroscopes
- Device Class
- Class IIa
- Market of Registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- CN-MF-000021400
- Authorised representative
- Umedwings Netherlands B.V. NL-AR-000000444
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Properties & raw data
Show properties, registry sources and raw records
Other properties (12)
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
Sources (1)
- EUDAMED 8338643c-07af-499f-a3a5-77a1f9145991