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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

12201501 — Class I MDR by CARDIVAIS S.A.

MD Atlas
CARDIVAIS S.A.

EUDAMED last updated this device on Jan 14, 2026

12201501

842965905804L8

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: CARDIVAIS S.A.
UDI-DI code: 08429659002050
Reference / catalog number: 12201501

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Manufacturer information

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

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12002220842965905805LAOn the market 16130500842965905808LGOn the market 16100202842965905806LCOn the market 16110000842965905809LJOn the market 425001/01842965905796M2On the market

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.

Placed on the market in Spain; per-country availability dates not published.

Device identification

Trade name: not provided
UDI-DI code: 08429659002050
Basic UDI-DI: 842965905804L8
Reference / catalog number: 12201501
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: Sterile protective gowns Intended use to provide a protective barrier between the user and their environment, minimizing the risk of cross-contamination in non-surgical clinical or healthcare settings.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

T0205NON-SURGICAL GOWNS (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE)

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