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EUDAMED last updated this device on Jul 22, 2026
426030671NONST8DSugi iSpear (pointed tip), round light blue handle, non-sterile, 500 x 6 pcs. is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by QUESTALPHA GmbH & Co. KG. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
0426030671041630670(01)04260306710416
European Medical Device Nomenclature — the EU product classification assigned to this device.
M040299NON-ADHESIVE ABSORBENT DRESSINGS - OTHERDE-MF-000005033The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
Primary placement in Germany; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| GermanyPrimary placement | — | 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 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 →426030671WIPEX9EOn the marketSugi iSpear (pointed tip), round green handle, non-sterile, 500 x 10 pcs.426030671NONST8DOn the marketSugi iSpear (pointed tip), round light blue handle, non-sterile, 500 x 10 pcs.426030671NONST8DOn the marketSugi iSpear (sharp tip), round dark blue handle, non-sterile, 500 x 10 pcs.426030671NONST8DOn the marketSugi Rhino Sheets, 80 x 90 mm, sterile, 10 x 1 pc.426030671ENTD8On the marketSugi Rhino Strips, 200 x 15 mm, sterile, 20 x 1 pc.426030671ENTD8On the market