Identity
- Device Name
- Sterile Orthopedic Suction Tubes EUDAMED
- Model / Reference
- MKOST-300 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977408663035 EUDAMED
- Basic UDI-DI
- 697740866MKOSTWH 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
Sterile Orthopedic Suction Tubes 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 | 697740866MKOSTWH | 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 16e23b78-b337-4731-908c-3e6510617bc3 61 fields · synced Jun 19, 2026