Identity
- Trade Name
- Convex array ultrasound probe EUDAMED
- Device Name
- Linear array ultrasound probe EUDAMED
- Model / Reference
- L25 EUDAMEDC60 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06945429024302 EUDAMED
- Basic UDI-DI
- 69454290UP001RN EUDAMED
- Direct Marketing DI
- 06945429024302 EUDAMED
- EMDN Code
- Z11040104 MULTIDISCIPLINARY ULTRASOUND SCANNERS (INTERNAL AND CARDIOLOGY, ETC.) EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Belgium 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Convex array ultrasound probe by Shenzhen Comen Medical Instruments Co., LTD. — Class IIa — 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 | 69454290UP001RN | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shenzhen Comen Medical Instruments Co., LTD.
- EUDAMED SRN
- CN-MF-000002236
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 06e9b641-7a5d-4b99-95b7-c5345e72aea6 61 fields · synced Jul 21, 2026