MRC Systems GmbH Medizintechnische Systeme
DE-MF-000011848 · Germany · Heidelberg
MRC Systems GmbH Medizintechnische Systeme is registered in the European database on medical devices as a manufacturer, with 57 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 57 |
|---|
Most frequent device types declared: EPS-P10, MRCAM, MRCAM-LED, OptiHair2, PinPrick Trigger.
Among these devices, 13 are declared active.
Devices declared under this manufacturer
- 12M
- HighResolution
- MR-LED-ARRAY-18X
- OptiHair2 0.5mN
- OptiHair2 16mN
- OptiHair2 1mN
- OptiHair2 256mN
- OptiHair2 8mN
- PinPrick PP05 256mN
- PinPrick PP05 512mN
- PinPrick PP06
- PinPrick PP06 128mN
Showing 12 of 57 declared devices.
Catalogue references include MR-LED-ARRAY-18X, OptiHair2 0.5mN, OptiHair2 1mN, OptiHair2 256mN, OptiHair2 8mN, PinPrick PP05 256mN.
European nomenclature codes declared: Z12101106, Z12101180, Z11039010, Z129004.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | MRC SYSTEMS GMBH MEDIZINTECHNISCHE SYSTEME (DE) · FDA 3003533010 |
| Devices in EUDAMED | 57 |
| Country of registration | Germany |
Device-level evidence
| Devices with a numeric GTIN | 57 |
|---|---|
| Found in the U.S. device database | 17 |
| Share | 29.8 % |
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. MRC Systems GmbH Medizintechnische Systeme is registered in the United States but was not found in the Canadian register.