Identity
- Device Name
- Ultrasound Scanners EUDAMED
- Model / Reference
- PA16 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973914210022 EUDAMED
- Basic UDI-DI
- 697391421PA16JS EUDAMED
- Direct Marketing DI
- 06973914210022 EUDAMED
- EMDN Code
- Z11040103 PORTABLE ULTRASOUND SCANNERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy 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
Ultrasound Scanners by Beijing iTrason Technologies 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 | 697391421PA16JS | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Beijing iTrason Technologies Co., Ltd.
- EUDAMED SRN
- CN-MF-000032285
- Authorised Representative
- Caretechion GmbH DE-AR-000005946
Sources (1)
- EUDAMED a0ca95c2-d897-4f41-9e07-22842a258f9d 61 fields · synced Jul 24, 2026