Munich Surgical Imaging GmbH
DE-MF-000009644 · Germany · München
Munich Surgical Imaging GmbH is registered in the European database on medical devices as a manufacturer, with 5 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 5 |
|---|
Most frequent device types declared: V10710-01, V12200-01, V12404-01, V12400-01.
Among these devices, 5 are declared active.
Devices declared under this manufacturer
- ARRISCOPE
- Heidelberg OPERA
- SeeLuma
- iOCT Module
Catalogue references include V10035-01, V10710-01, V12200-01, V12400-01, V12404-01.
European nomenclature codes declared: Z12011101, Z12120121.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | MUNICH SURGICAL IMAGING GMBH (DE) · FDA 3024078476 |
| Devices in EUDAMED | 5 |
| Country of registration | Germany |
Device-level evidence
| Devices with a numeric GTIN | 5 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | MUNICH SURGICAL IMAGING GMBH |
What it holds in Canada
| Licences on record | 1 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 1 |
| First licensed | 2026-07-02 |
Licence types: System (1).
Licensed under: IOCT MODULE.
North American profile: Both markets. Munich Surgical Imaging GmbH is registered in both the United States and Canada.