GETEMED Medizin- und Informationstechnik AG
DE-MF-000012384 · Germany · Teltow
GETEMED Medizin- und Informationstechnik AG is registered in the European database on medical devices as a manufacturer, with 88 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 82 |
|---|---|
| Class IIb | 6 |
Most frequent device types declared: Download Cable, ECG-Cable, HeartX Recorder Docking Station, HeartX Recorder ECG Patch, HeartX Viewer.
Among these devices, 20 are declared active, 15 with a measuring function.
Devices declared under this manufacturer
- CM 3000 GETEMED PRESS-STUD ADAPT-SET 7PC DIGI
- CM 3000 GETEMED PRESS-STUD ADPT 1PC DIGI 0.6M YE
- Kabel CM 4000, 3lead, 3 channel, 80cm, AHA, GE Type
- Kabel CM 4000, 5lead, 2 channel, 80cm, IEC, GE Type
- Patientenkabel CM 3000, 5lead, 2 channel, 80cm
- Patientenkabel CM 3000, 7lead, 3 channel, 80cm
- SEER 1000 Holter leadwire set, five lead, two channel, 105 cm (41 in),
- SEER 1000 Holter leadwire set, five lead, two channel, 61cm (24 in), I
- SEER 1000 Holter leadwire set, seven lead, three channel, 105 cm (41 i
- SEER 1000 Holter leadwire set, seven lead, three channel, 61 cm (24in)
- SEER 1000 Holter leadwire set, seven lead, three channel, 75cm (29.5 i
- SEER 1000 Holter leadwire set, three lead, three channel, 105 cm (41 i
Showing 12 of 88 declared devices.
Catalogue references include 2014606-070 / 90235, 2014606-083 / 90227, 2067634-016 / 85025, 2067634-052 / 85030, 2104815-001 / 85026-G, 2104819-001 / 85029-G.
European nomenclature codes declared: Z12050480, Z1203020202, Z12050492, Z12050403, C020501, Z12050499.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | GETEMED MEDIZIN- UND INFORMATIONSTECHNIK AG (DE) · FDA 3004006614 |
| Devices in EUDAMED | 88 |
| Country of registration | Germany |
Device-level evidence
| Devices with a numeric GTIN | 88 |
|---|---|
| Found in the U.S. device database | 41 |
| Share | 46.6 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | GETEMED MEDIZIN-UND INFORMATIONSTECHNIK AG |
What it holds in Canada
| Licences on record | 10 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 8 |
| Class 3 devices | 2 |
| First licensed | 2008-04-22 |
Licence types: Device Family (5), Single Device (2), System (2), Device Group Family (1).
Licensed under: HOLTER RECORDERS, CARDIODAY, ECG CABLES, VITAGUARD VG 2100, VITAGUARD PATIENT MONITORS WITH SPO2, SEER 1000.
North American profile: Both markets. GETEMED Medizin- und Informationstechnik AG is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
HZ 1624046-1 | supplemented | 2025-10-09 |
HZ 1624046-1 | reissued | 2030-10-09 |