- Organization name
- UDI-DI code
- Reference / catalog number
EUDAMED data as of Sep 21, 2026
EUDAMED last updated this device on Sep 16, 2026
B-09120134310033newwaveALEX is an MDD-legacy medical device on the European market. It is classified as Class IIb. Manufactured by waveguide medical systems GmbH. Placed on the EU market in Austria. Explore certificates, regulatory status and the official record on MD Atlas.
09120134310033NW-A-SPC(01)09120134310033
European Medical Device Nomenclature — the EU product classification assigned to this device.
Z12011019MULTI–PLATFORM LASER1 warning recorded — scroll inside the panel to see all entries.
Primary placement in Austria; available across 2 countries total.
| Country | On market since | Until |
|---|---|---|
| AustriaPrimary placement | May 21, 2021 | Still on market |
| Germany | May 21, 2021 | Still on market |
AT-MF-000011200170776255Sterile
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 DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
UDI 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.
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
No 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.