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Sterile Ultrasound Probe Cover
EUDAMEDClass I (EU MDR)
Ref GLT-02Ref ELS-ADH-1500-gRef ELS-ADH-100-350-gRef TEE-46-25-g
Identity
- Trade Name
- Sterile Ultrasound Probe Cover Kit EUDAMED
- Device Name
- Sterile Ultrasound Probe Cover EUDAMEDSterile Ultrasound Probe Cover Kit EUDAMED
- Model / Reference
- GLT-02 EUDAMEDELS-ADH-1500-g EUDAMEDELS-ADH-100-350-g EUDAMEDTEE-46-25-g EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06927716900728 EUDAMED06927716901602 EUDAMED06927716902265 EUDAMED06927716902623 EUDAMED
- Basic UDI-DI
- 69277169002GLT001EX EUDAMED69277169002GLT003F3 EUDAMED
- EMDN Code
- T030199 COVERS, INSTRUMENTS AND EQUIPMENT - OTHER EUDAMEDZ11040185 ULTRASOUND SCANNERS - CONSUMABLES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy EUDAMEDIreland EUDAMEDGreece EUDAMED
Clinical & Handling
Sterile
Yes
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
Sterile 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 | 69277169002GLT001EX | Class I | Active |
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Manufacturer
- Manufacturer
- Shenzhen Rising Medical Co., Ltd
- EUDAMED SRN
- CN-MF-000036422
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (4)
- EUDAMED 77baa883-8cdb-48e1-aa3d-7d2496d89d0f 61 fields · synced Oct 6, 2026
- EUDAMED 54f17d91-db9c-4cde-b3bb-3ec7fb3fa8c0 61 fields · synced May 18, 2026
- EUDAMED ccd3bbb5-984f-4fa4-8fa4-8a53bbbf344c 61 fields · synced May 19, 2026
- EUDAMED d61853fc-b3f1-41bf-a719-75712734e9a6 61 fields · synced Aug 1, 2026