EUDAMED last updated this device on May 7, 2026

DK Score Pro Coronary Scoring Balloon Dilatation Catheter

69722536014CSL5K

On the marketClass III

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: DK Medical Technology Co., Ltd.
UDI-DI code: 06923533800876
Reference / catalog number: CSL-2710

DK Score Pro Coronary Scoring Balloon Dilatation Catheter is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class III. Manufactured by DK Medical Technology Co., Ltd.. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.

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EUDAMED last updated this device on May 7, 2026

DK Score Pro Coronary Scoring Balloon Dilatation Catheter

69722536014CSL5K

On the marketClass III

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: DK Medical Technology Co., Ltd.
UDI-DI code: 06923533800876
Reference / catalog number: CSL-2710

View device family (Basic UDI)

Device identification

Trade name: DK Score Pro Coronary Scoring Balloon Dilatation Catheter
UDI-DI code: 06923533800876
Basic UDI-DI: 69722536014CSL5K
Reference / catalog number: CSL-2710
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: The coronary scoring balloon dilation catheter packaged as sterile and intended for single use in a radiology suite/catheterization laboratory/operating room in conjunction with radiologic equipment for fluoroscopic imaging. The product is a rapid exchange catheter, which is made of Pebax and nylon material with a PTFE jacket covering the stainless steel hypo-tube. The device consists of a catheter with a non-compliant balloon attached at the distal tip. 3 scoring wires are attached on the surface of the balloon. The product is indicated for dilatation of intravascular stenotic lesions during coronary angioplasty.
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)06923533800876

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.

C010401020199PTCA DIALATION CATHETERS - OTHER

Critical warnings

No critical warnings reported for this device.

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

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement		Still on market

Device identification

Trade name: DK Score Pro Coronary Scoring Balloon Dilatation Catheter
UDI-DI code: 06923533800876
Basic UDI-DI: 69722536014CSL5K
Reference / catalog number: CSL-2710
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: The coronary scoring balloon dilation catheter packaged as sterile and intended for single use in a radiology suite/catheterization laboratory/operating room in conjunction with radiologic equipment for fluoroscopic imaging. The product is a rapid exchange catheter, which is made of Pebax and nylon material with a PTFE jacket covering the stainless steel hypo-tube. The device consists of a catheter with a non-compliant balloon attached at the distal tip. 3 scoring wires are attached on the surface of the balloon. The product is indicated for dilatation of intravascular stenotic lesions during coronary angioplasty.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

Manufacturer information

Organization name: DK Medical Technology Co., Ltd.
SRN: CN-MF-000011218
Manufacturer status: Active

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)06923533800876

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.

C010401020199PTCA DIALATION CATHETERS - OTHER

Critical warnings

No critical warnings reported for this device.

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.

M.2025.MDR.1065Withdrawn
Quality management systemNotified body: 2696Expiry: Mar 12, 2030
M.2025.MDR.1062Issued
Quality management systemNotified body: 2696Expiry: Feb 17, 2028
M.2025.MDR.1062-1Withdrawn
Technical documentationNotified body: 2696Expiry: Feb 17, 2028

Legacy certificates

Certificate number: M.2025.MDR.1062-1
Type: Technical documentation
Notified body: UDEM Adriatic d.o.o. (2696)
Validity: Feb 18, 2025 → Feb 17, 2028

Certificates covering this device

M.2025.MDR.1062-1Withdrawn
Technical documentationNotified body: 2696Expiry: Feb 17, 2028

All products by DK Medical Technology Co., Ltd.

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement		Still on market

DK Score Pro Coronary Scoring Balloon Dilatation Catheter

DK Score Pro Coronary Scoring Balloon Dilatation Catheter

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

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

Legacy certificates

Certificates covering this device

Related devices

Market distribution

Related searches

Manufacturer information

Certificates

Legacy certificates

Certificates covering this device

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