- Organization name
- UDI-DI code
- Reference / catalog number
EUDAMED last updated this device on Nov 18, 2022
87186278700047100U57100 LED Light Source is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by Cymo B.V.. Placed on the EU market in Netherlands. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
NL-MF-000003493(01)08718627870198
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
1 warning recorded — scroll inside the panel to see all entries.
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 Netherlands; available across 10 countries total.
| Country | On market since | Until |
|---|---|---|
| NetherlandsPrimary placement | Jun 25, 2021 | Still on market |
| Czechia | Feb 4, 2022 | Still on market |
| Germany | May 25, 2021 | Still on market |
| EL | Jan 11, 2022 | Still on market |
| France | Nov 8, 2022 | Still on market |
| Italy | Mar 11, 2022 | Still on market |
| Poland | May 25, 2021 | Still on market |
| Portugal | Feb 4, 2022 | Still on market |
| Romania | Mar 3, 2022 | Still on market |
| Slovakia | Mar 29, 2022 | 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.
08718627870198Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
87186278700047100U57100.01UDI 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.
Z12020402LIGHT SOURCES FOR ENDOSCOPY AND MINIMALLY INVASIVE SURGERYPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →No certificate specifically references this device's Basic UDI-DI.
No 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.87186278700016698UZOn the market6698 HD Endoscopy Camera Control Unit with Recording87186278700016698UZOn the market6698 HD Endoscopy Camera Head87186278700016698UZOn the marketvitra 4K1 Endoscopy Camera Control Unit87186278700066190VFOn the marketvitra 4K1 Endoscopy Camera Head87186278700066190VFOn the marketvitra LS1 LED Light Source87186278700047100U5On the market