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Ultrasound Transmission Gel (Non-Sterile)
EUDAMEDClass I (EU MDR)
Ref AQP-100Model AQP-100,AQP-200,AQP-2000;AQP-5000,AQP-X,AQP-Y,AQP-Z
Identity
- Device Name
- Ultrasound Transmission Gel (Non-Sterile) EUDAMED
- Model / Reference
- AQP-100,AQP-200,AQP-2000;AQP-5000,AQP-X,AQP-Y,AQP-Z EUDAMEDAQP-100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06927716901275 EUDAMED
- Basic UDI-DI
- 69277169008GEL002E2 EUDAMED
- EMDN Code
- Z11049085 VARIOUS ULTRASOUND INSTRUMENTS - 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
Ultrasound Transmission Gel (Non-Sterile) by Shenzhen Rising Medical 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 | 69277169008GEL002E2 | Class I | Active |
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Manufacturer
- Manufacturer
- Shenzhen Rising Medical Co., Ltd
- EUDAMED SRN
- CN-MF-000036422
- Authorised Representative
- HyperCert Limited B.V. NL-AR-000047746
Sources (1)
- EUDAMED f79fb2ab-d503-4df9-b76f-ff2ae27bbbfc 61 fields · synced Jun 18, 2026