VC2-9A
Ref _, /Model VC6-2
Active
CE MDR
Valid until
Not listed
FDA recalls
None foundDocuments
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number69458686P1006QU | Date9 Sep 2023 | StatusActive |
| United States | GUDID listing GUDID | Number06945868614973 | Date28 Aug 2018 | StatusListed |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- VC2-9A EUDAMEDsonoscape GUDID
- Generic Name
- Extracorporeal ultrasound imaging transducer, hand-held
- Device Name
- Ultrasonic Transducer
- Model / Reference
- VC6-2 EUDAMED_ EUDAMED/ EUDAMEDVC2-9A GUDID
- Primary DI / UDI-DI
- 06945868614973, 06945868602420
- Basic UDI-DI
- 69458686P1006QU
- Direct Marketing DI
- 0694586861497306945868602420
- 510(k) Number
- FDA Product Code
- IYN, IYO, ITX
- EMDN Code
- Z110402010202 Curvilinear transcutaneous multidimensional ultrasound probes (convex–array)
- GMDN Term
- Extracorporeal ultrasound imaging transducer, hand-held
- Device Class
- Class IIa EUDAMEDClass II GUDID
- Regulation Number
- 892.1550, 892.1560, 892.1570
- EU market of registration
- Netherlands
- GUDID distribution status
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Model / Reference | VC6-2 _ / | VC2-9A |
| Device Class | Class IIa | Class II |
Manufacturer details
- EUDAMED SRN
- CN-MF-000009623
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Other devices from Sonoscape Medical Corp.
Properties
Other properties (22)
- Sterile: No
- Single Use: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Lot / Batch Number: No
- Expiration Date: No
- Manufacturing Date: No