Instruments for functional explorations and therapeutic interventionsInstruments to support and monitor vital signsVital signs monitoring instruments
Vital signs telemetry instruments (ECG, NIPB, EtCO2, SpO2, respiration,...)
EMDN code Z12030206
Manufacturers registered in Europe (EUDAMED) 10
- On the market
- No longer marketed
- 93/42 Former directive, not yet certified under the MDR
- Click a manufacturer to see its full range, a model to open its EUDAMED record.
A model registered in EUDAMED is not necessarily sold in your country. Check availability and CE marking with the manufacturer.
Other manufacturers known in the United States (FDA) 18
Manufacturers selling this type of device in the United States according to the FDA, not yet in EUDAMED for this category. Some do sell in Europe: registration of devices already on the market is mandatory until 28 November 2026, and some are registered under their parent company’s name. The category is inferred automatically from the US classification and may include related products.
| Manufacturer | Country | Brands | FDA clearance |
|---|---|---|---|
| Medidata Solutions, Inc. | – | BioStamp nPoint™ BioStamp® BioStamp® nPoint | registered |
| HAPPY HEALTH, INC. | United States | Happy Health | registered |
| Camntech, Ltd. Present in Europe in other categories | United Kingdom | MotionWatch PRO-Diary | K132764 (2014) |
| ACTIGRAPH L.L.C. | United States | ActiGraph | K231532 (2023) |
| Braebon Medical Corp. Present in Europe in other categories | Canada | BRAEBON Ultima Body Position Sensor BRAEBON Ultima Body Position Sensor for Alice 5 | K981969 (1998) |
| CADWELL INDUSTRIES, INC. Present in Europe in other categories | United States | EasyNet | registered |
| CONVEXITY SCIENTIFIC LLC | – | Spire Health Remote Patient Monitoring System | registered |
| Neurovirtual USA, Inc. Present in Europe in other categories | United States | Neurovirtual | registered |
| OXEHEALTH LIMITED Present in Europe in other categories | United Kingdom | Oxevision Sleep system | K233618 (2024) |
| Ambulatory Monitoring, Inc. | United States | – | K251574 (2025) |
| Arbor Medical Innovations, LLC | United States | – | K233987 (2024) |
| Condor Instruments Ltda. - Epp | Brazil | – | K151784 (2016) |
| EVER PPE INC | United States | – | registered |
| INTOPS Co.,Ltd. | South Korea | – | registered |
| Katecho, Inc. | United States | – | registered |
| Pneumowave, Ltd. | United Kingdom | – | K243513 (2025) |
| Quipment | France | – | registered |
| SHENZHEN FENDA TECHNOLOGY CO., LTD. | China | – | registered |
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