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Sterile Bladder Irrigation Sets for Single Use
EUDAMEDClass I (EU MDR)
Ref KY-IR-6-1Ref KY-IR-6-5Ref KY-IR-6-4Ref KY-IR-6-6
Identity
- Trade Name
- Sterile Bladder Irrigation Sets for Single Use EUDAMED
- Device Name
- Sterile Bladder Irrigation Sets for Single Use EUDAMED
- Model / Reference
- KY-IR-6-1 EUDAMEDKY-IR-6-5 EUDAMEDKY-IR-6-4 EUDAMEDKY-IR-6-6 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955053702354 EUDAMED06955053702392 EUDAMED06955053702385 EUDAMED06955053702408 EUDAMED
- Basic UDI-DI
- 695505370235KY-IR-6-1PZ EUDAMED
- Direct Marketing DI
- 06955053702354 EUDAMED06955053702392 EUDAMED06955053702385 EUDAMED06955053702408 EUDAMED
- EMDN Code
- A03040201 BLADDER IRRIGATION KITS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain 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
Sterile Bladder Irrigation Sets for Single Use by Vitaimed Instrument Co., Ltd. — Class I — 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 | 695505370235KY-IR-6-1PZ | Class I | Active |
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Manufacturer
- Manufacturer
- Vitaimed Instrument Co., Ltd.
- EUDAMED SRN
- CN-MF-000033172
- Authorised Representative
- VITAIMED GmbH DE-AR-000029575
Sources (4)
- EUDAMED 86991e76-1ea2-430e-a10c-fdf556268a45 61 fields · synced Aug 1, 2026
- EUDAMED e5bca660-ee53-4bf6-97f9-6d6f0132e71d 61 fields · synced May 18, 2026
- EUDAMED bdf05273-8b59-42b0-bf73-670c2fd881a1 61 fields · synced May 18, 2026
- EUDAMED 78340ed2-b667-4556-b52f-be96f52fdc2f 61 fields · synced May 18, 2026