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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Organization name
UDI-DI code
Reference / catalog number

425001/01 — Class IIa MDR by CARDIVAIS S.A.

MD Atlas
CARDIVAIS S.A.

EUDAMED last updated this device on May 1, 2025

425001/01

842965905796M2

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: CARDIVAIS S.A.
UDI-DI code: 08429659069633
Reference / catalog number: 425001/01

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Manufacturer information

Organization name: CARDIVAIS S.A.
SRN: ES-MF-000017980
Manufacturer status: Active

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Critical warnings

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

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.

Market distribution

Primary placement in Spain; available across 1 country total.

Country	On market since	Until
SpainPrimary placement	Jan 13, 2025	Still on market

Device identification

Trade name: not provided
UDI-DI code: 08429659069633
Basic UDI-DI: 842965905796M2
Reference / catalog number: 425001/01
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: Surgical kit composed of different components of surgical covers plus other kind of basic and common components (fungible) to surgical procedures, packed and sterilized in a single packaging with an individual labeling. All components and therefore the final product are single use. Sterilization method is by EO.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

T0202SURGICAL PROCEDURAL KITS (EXCLUDING SURGICAL INSTRUMENT KITS)

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

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Certificates

Certificate health across this manufacturer's portfolio.

2025 PR 0047Issued
Quality assuranceNotified body: 0318Expiry: Apr 20, 2030
ES23/00000553Issued
Quality management systemNotified body: 1639Expiry: May 30, 2028