- Role
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- Date of registration
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EUDAMED last updated this device on May 11, 2026
69411650000000587NPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →Ultrasound Biopsy Kits is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by Suzhou Leapmed Healthcare Corporation. Placed on the EU market in Italy. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
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 →06941165003526Basic 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 →69411650000000587N10612402UDI 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 →(01)06941165003526
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
European Medical Device Nomenclature — the EU product classification assigned to this device.
Z11049085VARIOUS ULTRASOUND INSTRUMENTS - CONSUMABLES6 warnings recorded — scroll inside the panel to see all entries.
CW011CW010CW009CW001CW007CW032Sterile
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 →No certificate specifically references this device's Basic UDI-DI.
Primary placement in Italy; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| ItalyPrimary placement | Mar 1, 2026 | Still on market |
CN-MF-000013964Certificate health across this manufacturer's portfolio.
HZ 2175018-1ReissuedNotified 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 →HZ 2175018-1IssuedNotified 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 →69411650000000016ROn the marketDisposable Semi Automatic Biopsy Instruments69411650000000016ROn the marketDisposable Semi Automatic Biopsy Instruments69411650000000016ROn the marketBiopsy Guides69411650000000827KOn the marketBiopsy Guides69411650000000827KOn the market