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EUDAMED last updated this device on Dec 6, 2024
5745000308CMNCAPILLARYMCPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →Capillary Function ver. 16 is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by Cercare Medical A/S. Placed on the EU market in Denmark. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →05745000308217Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
View in glossary →5745000308CMNCAPILLARYMCCapillary Function ver. 16UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
View in glossary →(01)05745000308217
European Medical Device Nomenclature — the EU product classification assigned to this device.
Z110603PICTURE ARCHIVING AND COMMUNICATION SYSTEMSSterile
A sterile device is supplied free of viable micro-organisms — flagged so that it is handled, stored and used to preserve that sterile state.
View in glossary →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.
View in glossary →Contains latex
A "contains latex" flag warns that a device contains natural rubber latex, which can trigger allergic reactions in sensitive patients.
View in glossary →CMR substance
A CMR flag warns that a device contains a substance that is carcinogenic, mutagenic or toxic to reproduction above a defined threshold.
View in glossary →Endocrine-disrupting substance
An endocrine-disruptor flag warns that a device contains a substance with endocrine-disrupting properties above a defined threshold.
View in glossary →No certificate specifically references this device's Basic UDI-DI.
Primary placement in Denmark; available across 18 countries total.
| Country | On market since | Until |
|---|---|---|
| DenmarkPrimary placement | Dec 6, 2024 | Still on market |
| Austria | Dec 6, 2024 | Still on market |
| Belgium | Dec 6, 2024 | Still on market |
| Cyprus | Dec 6, 2024 | Still on market |
| Germany | Dec 6, 2024 | Still on market |
| Finland | Dec 6, 2024 | Still on market |
| France | Dec 6, 2024 | Still on market |
| Ireland | Dec 6, 2024 | Still on market |
| Iceland | Dec 6, 2024 | Still on market |
| Italy | Dec 6, 2024 | Still on market |
| Liechtenstein | Dec 6, 2024 | Still on market |
| Luxembourg | Dec 6, 2024 | Still on market |
| Malta | Dec 6, 2024 | Still on market |
| Netherlands | Dec 6, 2024 | Still on market |
| Norway | Dec 6, 2024 | Still on market |
| Poland | Dec 6, 2024 | Still on market |
| Sweden | Dec 6, 2024 | Still on market |
| XI | Dec 6, 2024 | Still on market |
DK-MF-000002148Certificate health across this manufacturer's portfolio.
G15 102958 0008IssuedNotified 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 →5745000308CMNCAPILLARYMCOn the marketCapillary Function ver. 155745000308CMNCAPILLARYMCOn the marketCapillary Function ver. 145745000308CMNCAPILLARYMCOn the marketCapillary Function ver. 185745000308CMNCAPILLARYMCOn the marketCercare Medical Neurosuite ver.185745000308CMNNEUROSUITEL7On the market