Identity
- Trade Name
- MSOT Frontier EUDAMED
- Device Name
- MSOT Frontier EUDAMED
- Model / Reference
- SYS-MSOTFrontier EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04262380070028 EUDAMED
- Basic UDI-DI
- 4262380070204TX 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 Frontier by iThera Medical GmbH — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Electromagnetic surgical navigation device tracking system.
- RTM 92 HS — I.A.E. INDUSTRIA APPLICAZIONI ELETTRONICHE S.P.A. · Class IIb
- Nadeln / Needles — REDA Instrumente GmbH · Class I
- Nadeln / Needles — REDA Instrumente GmbH · Class I
- IA091S — ALFAMED SRL · Class IIa
- Nadeln / Needles — REDA Instrumente GmbH · Class I
- Needle Holder — Shandong Chengwu Medical Products Factory · Class I
- XR90 System, LOGIQ, Upgrade Kit — MediView XR · Class II
- Nadeln / Needles — REDA Instrumente GmbH · Class I
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European Union No Longer Active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| EUDAMED | European Union | CE/MDR | 4262380070204TX | Class IIa | No Longer Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- iThera Medical GmbH
- EUDAMED SRN
- DE-MF-000010082
Sources (1)
- EUDAMED efa53b45-d2d5-46ba-a723-04a2c145bb16 61 fields · synced Jun 18, 2026