- Organization name
- UDI-DI code
- Reference / catalog number
EUDAMED last updated this device on Feb 28, 2024
B-04547451026280Synoptiscope is an MDD-legacy medical device registered in EUDAMED. It is classified as Class I. Manufactured by Inami & Co., Ltd.. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
04547451026280L-2510HBJP-MF-000040062DD60129973001(01)04547451026280
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 10 countries total.
| Country | On market since | Until |
|---|---|---|
| GermanyPrimary placement | Apr 1, 1985 | Still on market |
| Bulgaria | Apr 1, 1985 | Still on market |
| Czechia | Apr 1, 1985 | Still on market |
| EL | Apr 1, 1985 | Still on market |
| France | Apr 1, 1985 | Still on market |
| Hungary | Apr 1, 1985 | Still on market |
| Italy | Apr 1, 1985 | Still on market |
| Netherlands | Apr 1, 1985 | Still on market |
| Poland | Apr 1, 1985 | Still on market |
| Portugal | Apr 1, 1985 | Still on market |
European Medical Device Nomenclature — the EU product classification assigned to this device.
Q0209STRABISMUS DEVICESPrimary 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 →No certificate specifically references this device's Basic UDI-DI.
Certificate health across this manufacturer's portfolio.
HZ 2066720-1IssuedNotified 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 →