Instruments to support and monitor vital signsAnaesthesia and pulmonary ventilation support instrumentsAnaesthesia systems
Anaesthesia devices
EMDN code Z1203010101
Manufacturers registered in Europe (EUDAMED) 25
- 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) 24
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 |
|---|---|---|---|
| PARKER-HANNIFIN CORPORATION | United States | ANALGESIA GAS MIXER, DIGITAL MDM DELIVERY SYSTEM ANALGESIA GAS MIXER, MDM DELIVERY SYSTEM ANALGESIA GAS MIXER, RA DELIVERY SYSTEM INTL DMDM (STAND)-SPAIN INTL DMDM (STAND)-MIDDLE EAST MXR-1 FLUSH MTMUNIVER CAN | registered |
| ORICARE INC. | United States | A9800 Anesthesia Workstation | K131790 (2014) |
| Codonics, Inc. Present in Europe in other categories | United States | Codonics Safe Label System®(SLS) 500i Point of Care Station Codonics SLS500i Operating Software Codonics Safe Label System®(SLS) 550i Point of Care Station Codonics Safe Label System® Administration Tool Codonics Safe Label System®(SLS) 610i Point of Care Station - 170C Codonics Safe Label System®(SLS) 620i Point of Care Station - 170C | K251352 (2025) |
| SPACELABS HEALTHCARE (WASHINGTON), INC Present in Europe in other categories | – | Spacelabs Healthcare BleaseFocus 900 Series Ventilator BleaseGenius | registered |
| Avante | – | Integra SL Integra SP VS02 Integra SL3 | registered |
| ADVANCED INSTRUMENTATIONS, INC. | United States | ADVANCED GAS-MACHINE ANESTHESIA | K120075 (2012) |
| Infinium Medical | United States | Infinium Medical Inc. | registered |
| MCKESSON TECHNOLOGIES INC. | United States | McKesson Anesthesia Care | K113633 (2012) |
| Beijing Aeomed Co., Ltd. | China | – | registered |
| Draegerwerk AG & CO Kgaa | Germany | – | registered |
| Flextronics International USA, Inc. | United States | – | registered |
| GALEMED CORPORATION Present in Europe in other categories | Taiwan | – | registered |
| GE HealthCare Technologies Inc. Present in Europe in other categories | United States | – | registered |
| Gamamed Vascular Systems Inc. | United States | – | registered |
| ICU MEDICAL, INC. Present in Europe in other categories | United States | – | registered |
| Makar Consulting Pty Ltd | Australia | – | registered |
| Mindray DS USA, Inc. | United States | – | K102471 (2011) |
| ORTA MEDICAL LTD | Israel | – | registered |
| PRECISION FLUIDICS DIVISION PARKER HANNIFIN CORP. | United States | – | registered |
| Philips Medical Systems Nederland B.V. Present in Europe in other categories | Netherlands | – | K083413 (2008) |
| Shenzhen Prunus Medical Co.,Ltd. Present in Europe in other categories | China | – | registered |
| Spacelabs Healthcare Present in Europe in other categories | United States | – | registered |
| Thornhill Medical | Canada | – | registered |
| Worldwide Supplies Limited | Hong Kong SAR China | – | registered |
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