- Role
- Country
- Date of registration
- Address
US-MF-00000210210000408810-PA-NA-DNKNo 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.General Purpose Temperature Probe, Soft is an MDD-legacy medical device registered in EUDAMED. It is classified as Class IIb. Manufactured by DeRoyal Industries, Inc.. Placed on the EU market in Netherlands. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on Oct 2, 2024
B-00749756820929Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)00749756820929
6 warnings recorded — scroll inside the panel to see all entries.
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 Netherlands; available across 32 countries total.
| Country | On market since | Until |
|---|---|---|
| NetherlandsPrimary placement | May 9, 2013 | Still on market |
| Austria | May 9, 2013 | Still on market |
| Belgium | May 9, 2013 | Still on market |
| Bulgaria | May 9, 2013 | Still on market |
| Cyprus | May 9, 2013 | Still on market |
| Czechia | May 9, 2013 | Still on market |
| Germany | May 9, 2013 | Still on market |
| Denmark | May 9, 2013 | Still on market |
| Estonia | May 9, 2013 | Still on market |
| EL | May 9, 2013 | Still on market |
| Spain | May 9, 2013 | Still on market |
| Finland | May 9, 2013 | Still on market |
| France | May 9, 2013 | Still on market |
| Croatia | May 9, 2013 | Still on market |
| Hungary | May 9, 2013 | Still on market |
| Ireland | May 9, 2013 | Still on market |
| Iceland | May 9, 2013 | Still on market |
| Italy | May 9, 2013 | Still on market |
| Liechtenstein | May 9, 2013 | Still on market |
| Lithuania | May 9, 2013 | Still on market |
| Luxembourg | May 9, 2013 | Still on market |
| Latvia | May 9, 2013 | Still on market |
| Malta | May 9, 2013 | Still on market |
| Norway | May 9, 2013 | Still on market |
| Poland | May 9, 2013 | Still on market |
| Portugal | May 9, 2013 | Still on market |
| Romania | May 9, 2013 | Still on market |
| Sweden | May 9, 2013 | Still on market |
| Slovenia | May 9, 2013 | Still on market |
| Slovakia | May 9, 2013 | Still on market |
| Türkiye | May 9, 2013 | Still on market |
| XI | May 9, 2013 | 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.
00749756820929Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
B-0074975682092981-02S412EUUDI 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.
V03010299BODY TEMPERATURE MONITORING PROBES - OTHERB-00749756984089On the marketGeneral Purpose Temperature ProbeB-00749756596565On the marketGeneral Purpose Temperature ProbeB-00749756301657On the marketGeneral Purpose Temperature Probe, SoftB-00749756820912On the marketHand Control Mitten07497560861036TOn the marketHand Control Mitten07497560861036TOn the marketNo certificate specifically references this device's Basic UDI-DI.