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Single-use Cystoscope
EUDAMEDClass IIa (EU MDR)
Ref PCS24-1Model 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, PCS24-6Ref PCS24-5Ref PCS12-1Ref PCS22-6Ref PCS22-4Ref PCS24-3Ref PCS24-6Ref PCS22-2Ref PCS22-1
Identity
- Device Name
- Single-use Cystoscope EUDAMED
- 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 EUDAMEDPCS24-1 EUDAMEDPCS24-5 EUDAMEDPCS12-1 EUDAMEDPCS22-6 EUDAMEDPCS22-4 EUDAMEDPCS24-3 EUDAMEDPCS24-6 EUDAMEDPCS22-2 EUDAMEDPCS22-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975202772885 EUDAMED06975202773455 EUDAMED06975202777408 EUDAMED06975202773417 EUDAMED06975202777460 EUDAMED06975202773431 EUDAMED06975202773462 EUDAMED06975202777446 EUDAMED06975202777439 EUDAMED
- Basic UDI-DI
- 697520277YS020L5 EUDAMED
- Direct Marketing DI
- 06975202772885 EUDAMED06975202773455 EUDAMED06975202777408 EUDAMED06975202773417 EUDAMED06975202777460 EUDAMED06975202773431 EUDAMED06975202773462 EUDAMED06975202777446 EUDAMED06975202777439 EUDAMED
- EMDN Code
- Z12020711 VIDEO CYSTOURETHROSCOPES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Single-use Cystoscope by Hunan Endoso Life Technology Co., Ltd — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697520277YS020L5 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Hunan Endoso Life Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000021400
- Authorised Representative
- Umedwings Netherlands B.V. NL-AR-000000444
Sources (9)
- EUDAMED c8d025e3-c1b0-4fa3-9731-6620253c5f4b 61 fields · synced Sep 18, 2026
- EUDAMED 63e70d0f-4455-4893-bf80-df1b45440074 61 fields · synced May 17, 2026
- EUDAMED ffbf3286-d87a-45c1-a413-90d05cef2087 61 fields · synced May 17, 2026
- EUDAMED 8338643c-07af-499f-a3a5-77a1f9145991 61 fields · synced May 17, 2026
- EUDAMED b61f631c-bedf-43db-a49e-6f2b5d2a77d5 61 fields · synced May 18, 2026
- EUDAMED fd64391b-2f37-401a-b942-017a97acf03e 61 fields · synced May 18, 2026
- EUDAMED dd0b482b-1657-45e6-b3aa-a553e8c1d085 61 fields · synced May 18, 2026
- EUDAMED 71169175-3064-4d29-9f5e-b76982de0f86 61 fields · synced May 18, 2026
- EUDAMED 962be2ad-619b-405f-9ceb-95096eca4adb 61 fields · synced May 18, 2026