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Ultrasound Probe Cover
EUDAMEDClass I (EU MDR)
Ref LLX-ZModel GQK-60-44-240, GQK-60-44-300, GQK-83-44-240, GQK-83-44-300, GQK-X, GQK-Y, GQK-Z; LLX-D33-240-blk, LLX-D33-300-blk, LLX-X, LLX-Y, LLX-Z;
Identity
- Device Name
- Ultrasound Probe Cover EUDAMED
- Model / Reference
- GQK-60-44-240, GQK-60-44-300, GQK-83-44-240, GQK-83-44-300, GQK-X, GQK-Y, GQK-Z; LLX-D33-240-blk, LLX-D33-300-blk, LLX-X, LLX-Y, LLX-Z; EUDAMEDLLX-Z EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06927716901428 EUDAMED
- Basic UDI-DI
- 69277169002GLT002EZ EUDAMED
- EMDN Code
- T030102 COVER SHEATHS, INSTRUMENTS AND EQUIPMENTS 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 Probe Cover 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 | 69277169002GLT002EZ | 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 aaaec5c8-caa6-4a74-b463-ba0d47230b19 61 fields · synced Oct 6, 2026