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EUDAMED last updated this device on May 7, 2026
69411650000000687RDisposable Automatic Core Biopsy Instruments is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by Suzhou Leapmed Healthcare Corporation. Placed on the EU market in Italy. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
0694116505420711306702CN-MF-000013964(01)06941165054207
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
6 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.
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 Italy; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| ItalyPrimary placement | Mar 1, 2026 | Still on market |
European Medical Device Nomenclature — the EU product classification assigned to this device.
A01020199NEEDLES AND KITS FOR HISTOLOGICAL AND CYTOLOGICAL BIOPSY OF SOFT TISSUES - 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 →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 →Certificate health across this manufacturer's portfolio.
HZ 2175018-1ReissuedHZ 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 →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 →No certificate specifically references this device's Basic UDI-DI.
69411650000000056ZOn the marketDisposable Automatic Core Biopsy Instruments694116500000000673On the marketDisposable Automatic Core Biopsy Instruments69411650000000056ZOn the marketDisposable Automatic Core Biopsy Instruments69411650000000056ZOn the marketDisposable Automatic Core Biopsy Instruments69411650000000056ZOn the marketDisposable Automatic Core Biopsy Instruments69411650000000687ROn the market