4K1101

Organization name

CARDIVAIS S.A.

SRN

ES-MF-000017980

Manufacturer status

Active

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

• CW010

  EUDAMED did not publish a description for this code.
• CW009

  EUDAMED did not publish a description for this code.
• CW007

  EUDAMED did not publish a description for this code.
• CW001

  EUDAMED did not publish a description for this code.

Primary placement in Spain; available across 5 countries total.

Trade name

not provided

UDI-DI code

08429659024328

Basic UDI-DI

842965905794LW

Reference / catalog number

4K1101

Issuing entity

GS1

Risk category

Class IIa

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

Single use sterile kit for use in cardiology angioplasty procedures. The kit includes the inflation device which is used to inflate the angioplasty balloon with a solution of contrast media and saline solution and other components that are needed for this process.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• C0104010280INTERVENTIONAL CORONARY ANGIOGRAPHY DEVICES - ACCESSORIES

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

Certificate health across this manufacturer's portfolio.