EUDAMED last updated this device on Mar 17, 2026

Tubing Systems and Accessories for Fluid Delivery

602147CMSET5T

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Sky Medical a.s.
UDI-DI code: 18586021474550
Reference / catalog number: CM-LS1020

Tubing Systems and Accessories for Fluid Delivery is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by Sky Medical a.s.. Placed on the EU market in Slovakia. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.

Role
Country
Date of registration
Address

EUDAMED last updated this device on Mar 17, 2026

Tubing Systems and Accessories for Fluid Delivery

602147CMSET5T

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Sky Medical a.s.
UDI-DI code: 18586021474550
Reference / catalog number: CM-LS1020

View device family (Basic UDI)

Device identification

Trade name: Tubing Systems and Accessories for Fluid Delivery
UDI-DI code: 18586021474550
Basic UDI-DI: 602147CMSET5T
Reference / catalog number: CM-LS1020
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: Contrast Media Delivery Set is intended for the infusion and/or administration of contrast media. Specifically, for injection of contrast media to patients.
Additional information URL: https://www.med-sky.com/
Clinical sizes: 20 MU10

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)18586021474550

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.

A03020102HIGH PRESSURE EXTENSION LINES

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW999
The device is designed and intended for single use only. Do not autoclave, reshape, re‑sterilize or reuse. Exposure to high heat may cause changes to the functionality of the 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 covering this device

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

Market distribution

Primary placement in Slovakia; available across 1 country total.

Country	On market since	Until
SlovakiaPrimary placement		Still on market

Device identification

Trade name: Tubing Systems and Accessories for Fluid Delivery
UDI-DI code: 18586021474550
Basic UDI-DI: 602147CMSET5T
Reference / catalog number: CM-LS1020
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: Contrast Media Delivery Set is intended for the infusion and/or administration of contrast media. Specifically, for injection of contrast media to patients.
Additional information URL: https://www.med-sky.com/
Clinical sizes: 20 MU10

Manufacturer information

Organization name: Sky Medical a.s.
SRN: SK-MF-000001475
Manufacturer status: Active

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)18586021474550

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.

A03020102HIGH PRESSURE EXTENSION LINES

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW999
The device is designed and intended for single use only. Do not autoclave, reshape, re‑sterilize or reuse. Exposure to high heat may cause changes to the functionality of the 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.

ITH 1450762 1Supplemented
Quality management systemNotified body: 1936Expiry: Nov 22, 2027

Certificates covering this device

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

All products by Sky Medical a.s.

Market distribution

Primary placement in Slovakia; available across 1 country total.

Country	On market since	Until
SlovakiaPrimary placement		Still on market

Tubing Systems and Accessories for Fluid Delivery

Tubing Systems and Accessories for Fluid Delivery

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

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