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EUDAMED last updated this device on Jul 22, 2026
426030671OPHT8MSugi Eyespear (blunt tip), rectangular white handle, sterile, 20 x 10 pcs. is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by QUESTALPHA GmbH & Co. KG. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
DE-MF-000005033(01)04260306710133
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
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 1 country total.
| Country | On market since | Until |
|---|---|---|
| GermanyPrimary placement | — | 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.
04260306710133Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
426030671OPHT8M30901UDI 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.
M040299NON-ADHESIVE ABSORBENT DRESSINGS - OTHERPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →426030671WIPE94On the marketSugi Eyedrain, 155 x 4 x 1 mm, non-sterile, 100 pcs.426030671NONST8DOn the marketSugi Eyedrain, 155 x 4 x 1 mm, sterile, 20 x 1 pc.426030671OPHT8MOn the marketSugi Eyespear (pointed tip), 17 x 7 mm, non-sterile, 50 x 10pcs.426030671NONST8DOn the marketSugi Eyespear (pointed tip), 17 x 7 mm, non-sterile, 500 x 10 pcs.426030671NONST8DOn the marketSugi Eyespear (pointed tip), rectangular white handle, non-sterile, 20x10 pcs.426030671NONST8DOn the marketNo certificate specifically references this device's Basic UDI-DI.
Certificate health across this manufacturer's portfolio.
G26 110417 0005ReissuedG15 110417 0006ReissuedNotified 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 →Notified 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 →