Identity
- Trade Name
- Ultrasound Gel EUDAMED
- Device Name
- Ultrasound Gel EUDAMED
- Model / Reference
- Item No.ULT0250 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06956907431017 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
Category: Device sterilization/disinfection container, reusable
Ultrasound Gel by Nantong Health &Beyond Hygienic Products Inc — Class I — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 69569074NULA4 | Class I | Active |
| 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 a47ae508-6c6e-4d63-a46e-033a7232ee0a 61 fields · synced Oct 7, 2026