- Role
- Country
- Date of registration
- Address
KR-MF-000020017VIVIX-S 1717V is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by Vieworks Co., Ltd.. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on Feb 2, 2024
880939433VIVIXS1717V2YPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)08809394330258
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
3 warnings recorded — scroll inside the panel to see all entries.
If the user is not fully aquainted with this manual, the product can be malfunctioned, or unsuspected problem can be happened due to carelessness. To prevent any medical accidents, the user should fully understand the instructions of this manual before operating this product.
OTHER
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 14 countries total.
| Country | On market since | Until |
|---|---|---|
| GermanyPrimary placement | Jul 10, 2020 | Jan 9, 2029 |
| Austria | Jul 10, 2020 | Jan 9, 2029 |
| Belgium | Jul 10, 2020 | Jan 9, 2029 |
| Czechia | Jul 10, 2020 | Jan 9, 2029 |
| Denmark | Jul 10, 2020 | Jan 9, 2029 |
| EL | Jul 10, 2020 | Jan 9, 2029 |
| France | Jul 10, 2020 | Jan 9, 2029 |
| Hungary | Jul 10, 2020 | Jan 9, 2029 |
| Italy | Jul 10, 2020 | Jan 9, 2029 |
| Netherlands | Jul 10, 2020 | Jan 9, 2029 |
| Poland | Jul 10, 2020 | Jan 9, 2029 |
| Slovakia | Jul 10, 2020 | Jan 9, 2029 |
| Türkiye | Jul 10, 2020 | Jan 9, 2029 |
| XI | Jul 10, 2020 | Jan 9, 2029 |
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
08809394330258Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
880939433VIVIXS1717V2YFXRD-1717VBUDI 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.
Z11031180SYSTEMS FOR DIRECT DIGITAL RADIOLOGY (DR) - HARDWARE ACCESSORIESNo certificate specifically references this device's Basic UDI-DI.
Certificate health across this manufacturer's portfolio.
C658257IssuedNotified 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 →