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EUDAMED last updated this device on Feb 5, 2026
08406821BUG004957R5976240 is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by GE Medical Systems CO. Ltd. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
001989530372945976240(01)00198953037294
European Medical Device Nomenclature — the EU product classification assigned to this device.
Z11040101INTERNAL ULTRASOUND SCANNERS1 warning recorded — scroll inside the panel to see all entries.
CW027Primary placement in Germany; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| GermanyPrimary placement | Jul 10, 2025 | Jul 12, 2025 |
CN-MF-000001856The 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.
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.
8406821BUG00204GWOn the marketVersana Premier R3 VA/ 59385598406821BUG00189HTOn the marketVivid T9 v206/58769488406821BUG00255HFOn the marketVivid T8 v206/58769558406821BUG00255HFOn the market58878828406821BUG00287HUOn the marketVivid iq v204 to v206 UPG SW only/58862768406821BUG00254HDOn the marketCertificate health across this manufacturer's portfolio.
HZ 2096373-1ReissuedHZ 2096373-1SupplementedNotified 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 →