← Back to catalogue
Medical Ultrasound Coupling Agent
EUDAMEDClass I (EU MDR)
Ref 80gModel 80g~500g/bottle
Identity
- Device Name
- Medical Ultrasound Coupling Agent EUDAMED
- Model / Reference
- 80g~500g/bottle EUDAMED80g EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974459969963 EUDAMED
- Basic UDI-DI
- 697445996AYMUCA4J EUDAMED
- EMDN Code
- Z12010885 INSTRUMENTS FOR ULTRASONIC SURGERY - CONSUMABLES 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 Ultrasound Coupling Agent by Shandong Kenuode Biomedical 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 | 697445996AYMUCA4J | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shandong Kenuode Biomedical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000047503
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED d28d47d9-e501-4a2c-9eae-f305bbfc30eb 61 fields · synced Jul 9, 2026