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EUDAMED last updated this device on Aug 11, 2023
B-29556564094849Protective Transducer Cover is an MDD-legacy medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by Karex Industries Sdn. Bhd.. Placed on the EU market in Czechia. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
29556564094849KX06(01)29556564094849
European Medical Device Nomenclature — the EU product classification assigned to this device.
Z11040185ULTRASOUND SCANNERS - CONSUMABLES5 warnings recorded — scroll inside the panel to see all entries.
Do not reuse transducer covers. Reuse or reprocessing may create a risk of contamination of the device and cause patient infection or cross-infection.
Use only water-based lubricant, avoid petroleum or mineral oil-based lubricant that may harm the covers.
Before use, you should be trained in ultrasonography.
OTHER
Primary placement in Czechia; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| CzechiaPrimary placement | — | May 26, 2024 |
MY-MF-000001247G2 102558 0003 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.
9556564-NMCM-U4On the marketPreventor Classic SensitiveB-09556564094814On the marketProtective Transducer CoverB-29556564094832On the marketProtective Transducer CoverB-29556564093286On the marketProtégé sondesB-09556564094494On the marketSoftB-09556564088578On the marketCertificate health across this manufacturer's portfolio.
G10 102558 0008IssuedNotified 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.
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