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Medical Screen
EUDAMEDClass I (EU MDR)
Ref SKH049-7 Model SKH049,SKH049-2,SKH049-3,SKH049-5,SKH049-6,SKH049-7,etc
Identity
- Device Name
- Medical Screen EUDAMED
- Model / Reference
- SKH049,SKH049-2,SKH049-3,SKH049-5,SKH049-6,SKH049-7,etc EUDAMEDSKH049-7 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16974539960665 EUDAMED
- Basic UDI-DI
- 697453996MedicalScreenR9 EUDAMED
- Direct Marketing DI
- 16974539960665 EUDAMED
- EMDN Code
- V0880 MEDICAL SUPPORT EQUIPMENT - ACCESSORIES 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
Medical Screen by Jiangsu Saikang Medical Equipment 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 | 697453996MedicalScreenR9 | Class I | Active |
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Manufacturer
- Manufacturer
- Jiangsu Saikang Medical Equipment Co., Ltd
- EUDAMED SRN
- CN-MF-000002228
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED eabc34d3-b1ce-434a-a28e-c77089edcb53 61 fields · synced Oct 6, 2026