MacroMedics
NL-MF-000006068 · Netherlands · Moordrecht
MacroMedics is registered in the European database on medical devices as a manufacturer, with 674 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 674 |
|---|
Devices declared under this manufacturer
- Block 1 MR
- Block 2 MR
- BreastBoard SX™ Adap 5
- Handgrips for DSCP™ right
- HighBridgeSupport RE
- Low Bridge Support
- Mask LMCFC-9 set/10
- Mask REMCFC-9, set/10
- Mask SSPS™-FEVRO
- MaxSupport™ 35 MR
- MaxSupport™ S-D
- T-Grip for EagleBoard™ MR
Showing 12 of 674 declared devices.
Catalogue references include 110810, 116235, 116330, 117590, 120360, 121160.
European nomenclature codes declared: Z12011280, Z12011285.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | MACROMEDICS BV (NL) · FDA 3010701021 |
| Devices in EUDAMED | 674 |
| Country of registration | Netherlands |
Device-level evidence
| Devices with a numeric GTIN | 674 |
|---|---|
| Found in the U.S. device database | 177 |
| Share | 26.3 % |
Canadian market access
| Health Canada licence listing | Not found in the Canadian register |
|---|
⚠️ Canada lists no Class I devices at all — what that excludes.
North American profile: United States only. MacroMedics is registered in the United States but was not found in the Canadian register.