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EUDAMED last updated this device on May 7, 2026
69411650000000016RDisposable Semi Automatic 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 Türkiye. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
0694116504086669411650000000016R11100402(01)06941165040866
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.
A01020199NEEDLES AND KITS FOR HISTOLOGICAL AND CYTOLOGICAL BIOPSY OF SOFT TISSUES - OTHER6 warnings recorded — scroll inside the panel to see all entries.
CW010CW009CW001CW007CW032CW011No certificate specifically references this device's Basic UDI-DI.
Primary placement in Türkiye; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| TürkiyePrimary placement | Feb 1, 2026 | Still on market |
CN-MF-000013964No certificates registered for this manufacturer.
No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.