- Organization name
- UDI-DI code
- Reference / catalog number
EUDAMED data as of Aug 18, 2026
EUDAMED last updated this device on Jan 23, 2025
B-06941691927662Spo2 sensor is an MDD-legacy medical device on the European market. It is classified as Class IIb. Manufactured by Orantech Inc.. Placed on the EU market in Denmark. Explore certificates, regulatory status and the official record on MD Atlas.
06941691927662SSD-024-W09I(01)06941691927662
European Medical Device Nomenclature — the EU product classification assigned to this device.
C900301PULSE OXIMETER SENSORS1 warning recorded — scroll inside the panel to see all entries.
The probe should not be fixed at the site of tissue damage, and should not be used for blood oxygen monitoring in hyperactive patients.
CN-MF-000013859Primary placement in Denmark; available across 5 countries total.
| Country | On market since | Until |
|---|---|---|
| DenmarkPrimary placement | — | Still on market |
| Germany | — | Still on market |
| France | — | Still on market |
| Netherlands | — | Still on market |
| Poland | — | Still on market |
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 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.
G1 098084 0003 CL 098084 0005 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.No certificate specifically references this device's Basic UDI-DI.