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EUDAMED last updated this device on Apr 16, 2026
0850006610ISPXXDose Check is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by Amalgam Rx, Inc. Placed on the EU market in Italy. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
00860008440129DSC-XX-001 [XX = Refers to EU Country Code](01)00860008440129
European Medical Device Nomenclature — the EU product classification assigned to this device.
V92MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES2 warnings recorded — scroll inside the panel to see all entries.
The following contraindications apply to the use of Dose Check: Use by a person who is not an adult. Use by patients in the event of an emergency. Use by patients with type 1 diabetes. Use by patients with gestational diabetes. Use by patients using an insulin pump. Understand that while Dose Check displays guidance to help patients who report hypoglycemic and hyperglycemic blood sugar measurements, it is not to be used for management of emergencies. Please contact emergency services as directed by your healthcare professional.
Dose Check should only be used under the guidance and supervision of a healthcare professional.
Primary placement in Italy; available across 3 countries total.
| Country | On market since | Until |
|---|---|---|
| ItalyPrimary placement | May 19, 2023 | Still on market |
| Denmark | Nov 19, 2024 | Still on market |
| France | Sep 14, 2023 | Still on market |
US-MF-00002191228620177096Sterile
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 →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 →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.
View in glossary →UDI 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 →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.
View in glossary →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 →Certificate health across this manufacturer's portfolio.
28620177096IssuedNotified 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 →