Identity
- Trade Name
- MK Suction Irrigation Set EUDAMED
- Device Name
- Disposable Sterile Suction Irrigation Set EUDAMED
- Model / Reference
- MKSI0533 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977408662014 EUDAMED
- Basic UDI-DI
- 697740866MKSI01VR EUDAMED
- EMDN Code
- A06010103 CANNULAS AND TIPS FOR ASPIRATION AND IRRIGATION, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
MK Suction Irrigation Set by Zibo MK Medical 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 | 697740866MKSI01VR | Class IIa | Active |
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Manufacturer
- Manufacturer
- Zibo MK Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000045526
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 7cf0896c-1f5b-4e59-a0d1-57402a754a41 61 fields · synced Jul 23, 2026