Identity
- Trade Name
- LAP7 EUDAMEDsonoscape FDA UDI
- Generic Name
- Surgical ultrasound imaging transducer FDA UDI
- Device Name
- Ultrasonic Transducer EUDAMEDLAP7 Ultrasonic Transducer(X3) FDA UDI
- Model / Reference
- LAP7 EUDAMEDFDA UDI- EUDAMED
- Description
- LAP7 Ultrasonic Transducer(X3) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06945868603243 EUDAMEDFDA UDI06945868607678 EUDAMED06945868610944 EUDAMED
- Basic UDI-DI
- 69458686P1016QX EUDAMED
- Direct Marketing DI
- 06945868603243 EUDAMED06945868607678 EUDAMED06945868610944 EUDAMED
- 510(k) Number
- K163427 FDA UDI
- FDA Product Code
- ITX FDA UDIIYO FDA UDIIYN FDA UDI
- EMDN Code
- Z11040299 ULTRASOUND PROBES – OTHER EUDAMED
- GMDN Term
- Surgical ultrasound imaging transducer FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1570 FDA UDI892.1560 FDA UDI892.1550 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Lap7 by Sonoscape Medical Corp. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69458686P1016QX | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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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 (4)
- EUDAMED 8717d967-d235-4104-a38e-d641549f4816 61 fields · synced Oct 6, 2026
- EUDAMED da1d2e26-47f8-4816-abce-a6fd708c0690 61 fields · synced May 17, 2026
- EUDAMED bcdf6dad-4de1-4b60-8fed-cafad9b9bda5 61 fields · synced May 17, 2026
- FDA UDI 128437b2-84ac-4293-9be2-9694af84f905 34 fields · synced May 30, 2026