- Role
- Country
- Date of registration
- Address
US-MF-000002301DreamStation Link Module is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by Respironics Inc.. Placed on the EU market in Austria. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on May 27, 2026
0606959BM218LZPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)00606959022355
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
Sterile
A sterile device is supplied free of viable micro-organisms — flagged so that it is handled, stored and used to preserve that sterile state.
Single-use device
A single-use device is intended to be used on one patient during a single procedure and then discarded — not reprocessed or reused.
Contains latex
A "contains latex" flag warns that a device contains natural rubber latex, which can trigger allergic reactions in sensitive patients.
CMR substance
A CMR flag warns that a device contains a substance that is carcinogenic, mutagenic or toxic to reproduction above a defined threshold.
Endocrine-disrupting substance
An endocrine-disruptor flag warns that a device contains a substance with endocrine-disrupting properties above a defined threshold.
Primary placement in Austria; available across 27 countries total.
| Country | On market since | Until |
|---|---|---|
| AustriaPrimary placement | May 28, 2015 | Dec 31, 9999 |
| Belgium | May 28, 2015 | Dec 31, 9999 |
| Cyprus | May 28, 2015 | Dec 31, 9999 |
| Czechia | May 28, 2015 | Dec 31, 9999 |
| Germany | May 28, 2015 | Dec 31, 9999 |
| Denmark | May 28, 2015 | Dec 31, 9999 |
| Estonia | May 28, 2015 | Dec 31, 9999 |
| EL | May 28, 2015 | Dec 31, 9999 |
| Spain | May 28, 2015 | Dec 31, 9999 |
| Finland | May 28, 2015 | Dec 31, 9999 |
| France | May 28, 2015 | Dec 31, 9999 |
| Croatia | May 28, 2015 | Dec 31, 9999 |
| Hungary | May 28, 2015 | Dec 31, 9999 |
| Ireland | May 28, 2015 | Dec 31, 9999 |
| Iceland | May 28, 2015 | Dec 31, 9999 |
| Italy | May 28, 2015 | Dec 31, 9999 |
| Lithuania | May 28, 2015 | Dec 31, 9999 |
| Luxembourg | May 28, 2015 | Dec 31, 9999 |
| Latvia | May 28, 2015 | Dec 31, 9999 |
| Netherlands | May 28, 2015 | Dec 31, 9999 |
| Norway | May 28, 2015 | Dec 31, 9999 |
| Poland | May 28, 2015 | Dec 31, 9999 |
| Portugal | May 28, 2015 | Dec 31, 9999 |
| Romania | May 28, 2015 | Dec 31, 9999 |
| Sweden | May 28, 2015 | Dec 31, 9999 |
| Slovenia | May 28, 2015 | Dec 31, 9999 |
| Slovakia | May 28, 2015 | Dec 31, 9999 |
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
00606959022355Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
0606959BM218LZ1120293UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
MDR risk classes
MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.
European Medical Device Nomenclature — the EU product classification assigned to this device.
Z1203019080VARIOUS INSTRUMENTS FOR ANAESTHESIA AND PULMONARY VENTILATION SUPPORT - HARDWARE ACCESSORIESB-00606959061040On the marketDreamStation Humidifier, RentalB-00606959412286On the marketDreamStation Humidifier, UkraineB-00606959058095On the marketDreamStation Micro-Flex PR12 Tube Starter PackB-00606959040502On the marketDreamStation REMstar Auto RentalB-00606959410817On the marketDreamStation REMstar Humidifier GER, RentalB-00606959410831On the marketNo certificate specifically references this device's Basic UDI-DI.
No certificates registered for this manufacturer.
No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.