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DE-MF-000007931Ovy App Android is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class IIb. Manufactured by Ovy GmbH. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on Apr 14, 2025
426059896001DTPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)04260598963354
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 Germany; available across 30 countries total.
| Country | On market since | Until |
|---|---|---|
| GermanyPrimary placement | Apr 14, 2025 | Still on market |
| Austria | Apr 14, 2025 | Still on market |
| Belgium | Apr 14, 2025 | Still on market |
| Bulgaria | Apr 14, 2025 | Still on market |
| Cyprus | Apr 14, 2025 | Still on market |
| Czechia | Apr 14, 2025 | Still on market |
| Denmark | Apr 14, 2025 | Still on market |
| Estonia | Apr 14, 2025 | Still on market |
| EL | Apr 14, 2025 | Still on market |
| Spain | Apr 14, 2025 | Still on market |
| Finland | Apr 14, 2025 | Still on market |
| France | Apr 14, 2025 | Still on market |
| Croatia | Apr 14, 2025 | Still on market |
| Hungary | Apr 14, 2025 | Still on market |
| Ireland | Apr 14, 2025 | Still on market |
| Iceland | Apr 14, 2025 | Still on market |
| Italy | Apr 14, 2025 | Still on market |
| Liechtenstein | Apr 14, 2025 | Still on market |
| Lithuania | Apr 14, 2025 | Still on market |
| Luxembourg | Apr 14, 2025 | Still on market |
| Latvia | Apr 14, 2025 | Still on market |
| Malta | Apr 14, 2025 | Still on market |
| Netherlands | Apr 14, 2025 | Still on market |
| Norway | Apr 14, 2025 | Still on market |
| Poland | Apr 14, 2025 | Still on market |
| Portugal | Apr 14, 2025 | Still on market |
| Romania | Apr 14, 2025 | Still on market |
| Sweden | Apr 14, 2025 | Still on market |
| Slovenia | Apr 14, 2025 | Still on market |
| Slovakia | Apr 14, 2025 | 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.
04260598963354Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
426059896001DTOvy App AndroidUDI 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.
V92MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSESCertificate health across this manufacturer's portfolio.
Z-22-116-S-IXIssuedNotified 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.
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