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EUDAMED last updated this device on Sep 3, 2024
4560126260041U5Wide field OCT attachment lens WA-1 is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by TOPCON CORPORATION. Placed on the EU market in Netherlands. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
04560126268105WA-1(01)04560126268105
European Medical Device Nomenclature — the EU product classification assigned to this device.
Z12120121OPTICAL CONSISTENCY TOMOGRAPHS1 warning recorded — scroll inside the panel to see all entries.
• We do not intend to use WA-1 for “Diagnosis with only the wide field tomogram”. Errors in diagnosis will occur. • To avoid injury of the patient, be careful not to bump the patient's eye or nose with the instrument when operating the touch display. • To avoid injury of the patient, be careful not to bump the patient's eye or nose with the Wide field OCT attachment lens when operating the control lever.
JP-MF-000003928The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
Primary placement in Netherlands; available across 2 countries total.
| Country | On market since | Until |
|---|---|---|
| NetherlandsPrimary placement | Aug 29, 2024 | Still on market |
| Spain | Aug 29, 2024 | Still on market |
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.
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 →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.4560126260110TXOn the marketWAVE-FRONT ANALYZER KR-1WB-04562123285345On the marketWAVE-FRONT ANALYZER KR-1WB-04562123289640On the marketPOWER SUPPLY UNIT for CV-5000 (PC EXTERNAL TYPE)4560126260111TZOn the market1 DIAL CONTROLLER KB-50S4560126260111TZOn the market1 DIAL CONTROLLER KB-50S 4560126260111TZOn the marketNo certificate specifically references this device's Basic UDI-DI.