- Organization name
- UDI-DI code
- Reference / catalog number
EUDAMED last updated this device on May 17, 2022
859421157DANFLOWPSDANFLOW Wave is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by MEDKONSULT medical technology s.r.o.. Placed on the EU market in Czechia. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
CZ-MF-0000161932022-MDR/QS-001/A(01)08594211570121
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 Czechia; available across 13 countries total.
| Country | On market since | Until |
|---|---|---|
| CzechiaPrimary placement | — | Still on market |
| Austria | — | Still on market |
| Belgium | — | Still on market |
| Bulgaria | — | Still on market |
| Germany | — | Still on market |
| Denmark | — | Still on market |
| Estonia | — | Still on market |
| Spain | — | Still on market |
| Italy | — | Still on market |
| Netherlands | — | Still on market |
| Poland | — | Still on market |
| Portugal | — | Still on market |
| Sweden | — | Still on market |
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
08594211570121Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
859421157DANFLOWPSFU1100UDI 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.
Z121605UROFLOWMETERSPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →859421157DANFLOWPSOn the marketDANFLOW Chord CU859421157DANFLOWPSOn the marketDANFLOW Chord PC859421157DANFLOWPSOn the marketDANFLOW Wave CU859421157DANFLOWPSOn the marketMMT Air-Charged Pressure Sensor859421157ATMOSK7On the marketMMT Air-Charged Pressure Sensor859421157ATMOSK7On the marketCertificate health across this manufacturer's portfolio.
2024-MDR/QS-054Issued2022-MDR/QS-001/BAmendedNotified body
A notified body is an independent organisation, designated by an EU country, that audits manufacturers and certifies higher-risk devices before they can be CE-marked.
View in glossary →Notified body
A notified body is an independent organisation, designated by an EU country, that audits manufacturers and certifies higher-risk devices before they can be CE-marked.
View in glossary →