Identity
- Trade Name
- Ultrasound Gel EUDAMED
- Device Name
- Ultrasound Gel EUDAMED
- Model / Reference
- Item No.ULT5000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06956907431000 EUDAMED
- Basic UDI-DI
- 69569074NULA4 EUDAMED
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France 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
Ultrasound Gel by Nantong Health &Beyond Hygienic Products Inc — 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 | 69569074NULA4 | Class I | Active |
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Manufacturer
- Manufacturer
- Nantong Health &Beyond Hygienic Products Inc
- EUDAMED SRN
- CN-MF-000009864
- Authorised Representative
- Kingsmead Service B.V. NL-AR-000002066
Sources (1)
- EUDAMED 0507f5e9-cb24-476b-91f0-8549dfbda934 61 fields · synced Oct 5, 2026