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Residual Contamination Test (visual)
EUDAMEDClass I (EU MDR)
Ref PRO2 10x33x46mmModel PRO2，5646854，HEMA2- 25，KCA-5820，KCS-5812，KCP-7815
Identity
- Device Name
- RESIDUAL CONTAMINATION TEST (VISUAL) EUDAMED
- Model / Reference
- PRO2，5646854，HEMA2- 25，KCA-5820，KCS-5812，KCP-7815 EUDAMEDPRO2 10x33x46mm EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974409693047 EUDAMED
- Basic UDI-DI
- 697440969RCTWB EUDAMED
- EMDN Code
- S0199 DEVICES FOR STERILISATION AND PACKAGING (EXCLUDING CAT. D - Z) - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
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
Residual Contamination Test (visual) by Mediwish 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 | 697440969RCTWB | Class I | Active |
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Manufacturer
- Manufacturer
- Mediwish Co., Ltd
- EUDAMED SRN
- CN-MF-000008849
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 0f4dcb7f-c003-48be-9600-12a278327806 61 fields · synced Jun 19, 2026