Identity
- Device Name
- Sterile Suture Organizer EUDAMED
- Model / Reference
- SO015-2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977408664049 EUDAMED
- Basic UDI-DI
- 697740866MKSO01WP EUDAMED
- EMDN Code
- H900899 SINGLE-USE INSTRUMENTS FOR SUTURES - OTHER EUDAMED
Classification
- Device Class
- Class I 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 Suture Organizer by Zibo MK Medical Technology 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 | 697740866MKSO01WP | Class I | 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 15c4be38-1a17-4314-9be3-5a064addec74 61 fields · synced Jun 18, 2026