EUDAMED last updated this device on May 11, 2026

Ultrasound Biopsy Kits

69411650000000587N

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Suzhou Leapmed Healthcare Corporation
UDI-DI code: 06941165003496
Reference / catalog number: 10612302

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 France. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.

Role
Country
Date of registration
Address

EUDAMED last updated this device on May 11, 2026

Ultrasound Biopsy Kits

69411650000000587N

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Suzhou Leapmed Healthcare Corporation
UDI-DI code: 06941165003496
Reference / catalog number: 10612302

View device family (Basic UDI)

Device identification

Trade name: Ultrasound Biopsy Kits
UDI-DI code: 06941165003496
Basic UDI-DI: 69411650000000587N
Reference / catalog number: 10612302
Issuing entity: GS1

Classification

Risk category: Class I
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Ultrasound Biopsy Kits, LPUBK03
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)06941165003496

UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

Z11049085VARIOUS ULTRASOUND INSTRUMENTS - CONSUMABLES

Critical warnings

6 warnings recorded — scroll inside the panel to see all entries.

CW011
EUDAMED did not publish a description for this code.
CW010
EUDAMED did not publish a description for this code.
CW009
EUDAMED did not publish a description for this code.
CW001
EUDAMED did not publish a description for this code.
CW007
EUDAMED did not publish a description for this code.
CW032
EUDAMED did not publish a description for this code.

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

Certificates covering this device

No certificate specifically references this device's Basic UDI-DI.

Market distribution

Primary placement in France; available across 1 country total.

Country	On market since	Until
FrancePrimary placement	Apr 1, 2026	Still on market

Device identification

Trade name: Ultrasound Biopsy Kits
UDI-DI code: 06941165003496
Basic UDI-DI: 69411650000000587N
Reference / catalog number: 10612302
Issuing entity: GS1

Classification

Risk category: Class I
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Ultrasound Biopsy Kits, LPUBK03
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

Manufacturer information

Organization name: Suzhou Leapmed Healthcare Corporation
SRN: CN-MF-000013964
Manufacturer status: Active

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)06941165003496

UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

Z11049085VARIOUS ULTRASOUND INSTRUMENTS - CONSUMABLES

Critical warnings

6 warnings recorded — scroll inside the panel to see all entries.

CW011
EUDAMED did not publish a description for this code.
CW010
EUDAMED did not publish a description for this code.
CW009
EUDAMED did not publish a description for this code.
CW001
EUDAMED did not publish a description for this code.
CW007
EUDAMED did not publish a description for this code.
CW032
EUDAMED did not publish a description for this code.

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

Certificates

Certificate health across this manufacturer's portfolio.

HZ 2175018-1Reissued
Quality management systemNotified body: 0197Expiry: Jun 6, 2029
HZ 2175018-1Issued
Quality management systemNotified body: 0197Expiry: Jun 6, 2029

Certificates covering this device

No certificate specifically references this device's Basic UDI-DI.

All products by Suzhou Leapmed Healthcare Corporation

Market distribution

Primary placement in France; available across 1 country total.

Country	On market since	Until
FrancePrimary placement	Apr 1, 2026	Still on market

Ultrasound Biopsy Kits

Ultrasound Biopsy Kits

Device identification

Classification

Device details

UDI-PI traceability

UDI-DI DataMatrix

UDI-PI DataMatrix

EMDN nomenclature code(s)

Critical warnings

Compliance flags

Safety

Substances

Regulatory

Lifecycle

Certificates covering this device

Market distribution

Related searches

Device identification

Classification

Device details

Manufacturer information

UDI-PI traceability

UDI-DI DataMatrix

UDI-PI DataMatrix

EMDN nomenclature code(s)

Critical warnings

Compliance flags

Safety

Substances

Regulatory

Lifecycle

Certificates

Certificates covering this device

Related devices

Market distribution

Related searches

Manufacturer information

Certificates

Related devices