Identity
- Trade Name
- LAP8L EUDAMED
- Device Name
- Ultrasonic Transducer EUDAMED
- Model / Reference
- LAP7 EUDAMED_ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06945868617202 EUDAMED
- Basic UDI-DI
- 69458686P1016QX EUDAMED
- Direct Marketing DI
- 06945868617202 EUDAMED
- EMDN Code
- Z11040299 ULTRASOUND PROBES – OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands 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
Lap8l by Sonoscape Medical Corp. — 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 | 69458686P1016QX | Class IIa | Active |
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Manufacturer
- Manufacturer
- Sonoscape Medical Corp.
- EUDAMED SRN
- CN-MF-000009623
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 30da6a05-c83a-4ca9-a69b-eefc9668ac76 61 fields · synced Jun 18, 2026