Identity
- Trade Name
- MSOT Acuity Echo EUDAMED
- Device Name
- MSOT Acuity Echo EUDAMED
- Model / Reference
- SYS-MSOTACUITYechoCE2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04262380070004 EUDAMED
- Basic UDI-DI
- 4262380070203TV EUDAMED
- Direct Marketing DI
- 04262380070004 EUDAMED
- EMDN Code
- Z11039099 VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS – OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
Category: Electromagnetic surgical navigation device tracking system
MSOT Acuity Echo by iThera Medical GmbH — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Electromagnetic surgical navigation device tracking system.
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union No Longer Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 4262380070203TV | Class IIa | No Longer Active |
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Manufacturer
- Manufacturer
- iThera Medical GmbH
- EUDAMED SRN
- DE-MF-000010082
Sources (1)
- EUDAMED 34469753-04f9-47cd-8b09-825a0d4124b5 61 fields · synced Jun 18, 2026