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Endoscopic Ultrasonic Probe
EUDAMEDClass IIa (EU MDR)
Ref N/AModel UM-2412， UM-2420, UM-1720
Identity
- Device Name
- Endoscopic Ultrasonic Probe EUDAMED
- Model / Reference
- UM-2412， UM-2420, UM-1720 EUDAMEDN/A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973614991009 EUDAMED
- Basic UDI-DI
- 697361499EU001K2 EUDAMED
- EMDN Code
- Z1104020301 TRANSESOPHAGEAL ULTRASOUND PROBES, TWO–DIMENSIONAL EUDAMED
Classification
- Device Class
- Class IIa 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
Endoscopic Ultrasonic Probe by Acoustic Life Science 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 | 697361499EU001K2 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Acoustic Life Science Co., Ltd.
- EUDAMED SRN
- CN-MF-000031218
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED ba81d635-f35b-4a37-a3c4-3b3dd9b01b4f 61 fields · synced Jun 18, 2026
- EUDAMED ba81d635-f35b-4a37-a3c4-3b3dd9b01b4f-1 61 fields · synced Jun 10, 2026