- Role
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- Date of registration
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US-MF-000000770Captus 4000e Thyroid Uptake System is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by Mirion Technologies (Capintec), Inc.. Placed on the EU market in France. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on Apr 24, 2024
08599420061014SPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)00859942006096
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 France; available across 32 countries total.
| Country | On market since | Until |
|---|---|---|
| FrancePrimary placement | Aug 31, 2015 | Still on market |
| Austria | Aug 31, 2015 | Still on market |
| Belgium | Aug 31, 2015 | Still on market |
| Bulgaria | Aug 31, 2015 | Still on market |
| Cyprus | Aug 31, 2015 | Still on market |
| Czechia | Aug 31, 2015 | Still on market |
| Germany | Aug 31, 2015 | Still on market |
| Denmark | Aug 31, 2015 | Still on market |
| Estonia | Aug 31, 2015 | Still on market |
| EL | Aug 31, 2015 | Still on market |
| Spain | Aug 31, 2015 | Still on market |
| Finland | Aug 31, 2015 | Still on market |
| Croatia | Aug 31, 2015 | Still on market |
| Hungary | Aug 31, 2015 | Still on market |
| Ireland | Aug 31, 2015 | Still on market |
| Iceland | Aug 31, 2015 | Still on market |
| Italy | Aug 31, 2015 | Still on market |
| Liechtenstein | Aug 31, 2015 | Still on market |
| Lithuania | Aug 31, 2015 | Still on market |
| Luxembourg | Aug 31, 2015 | Still on market |
| Latvia | Aug 31, 2015 | Still on market |
| Malta | Aug 31, 2015 | Still on market |
| Netherlands | Aug 31, 2015 | Still on market |
| Norway | Aug 31, 2015 | Still on market |
| Poland | Aug 31, 2015 | Still on market |
| Portugal | Aug 31, 2015 | Still on market |
| Romania | Aug 31, 2015 | Still on market |
| Sweden | Aug 31, 2015 | Still on market |
| Slovenia | Aug 31, 2015 | Still on market |
| Slovakia | Aug 31, 2015 | Still on market |
| Türkiye | Aug 31, 2015 | Still on market |
| XI | Aug 31, 2015 | 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.
00859942006096Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
08599420061014S5430-30151UDI 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.
Z11029001BETA/GAMMA DETECTORSNo certificate specifically references this device's Basic UDI-DI.
08599420061024UOn the marketBeta Syringe Shield, 10 cc08599420061024UOn the marketBeta Syringe Shield, 20 cc08599420061024UOn the marketCaptus 4000e Thyroid Uptake System with Well (1 in)08599420061014SOn the marketCaptus 4000e Thyroid Uptake System with Well (2 in)08599420061014SOn the marketCRC 55tR Dose Calibrator08599420061004QOn the marketNo 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.