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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

VKAXE12-080A3E-IT — Class IIa MDR by WINNCARE FRANCE

MD Atlas
WINNCARE FRANCE

EUDAMED last updated this device on May 27, 2026

VKAXE12-080A3E-IT

366489700083H9

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: WINNCARE FRANCE
UDI-DI code: 03664897034325
Reference / catalog number: VKAXE12-080A3E-IT

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View device family (Basic UDI)

Manufacturer information

Organization name: WINNCARE FRANCE
SRN: FR-MF-000000482
Manufacturer status: Active

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Certificates

Certificate health across this manufacturer's portfolio.

FR26/00000124Issued
Quality management systemNotified body: 1639Expiry: Apr 14, 2031

Critical warnings

No critical warnings reported for this device.

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Market distribution

Primary placement in Italy; available across 1 country total.

Country	On market since	Until
ItalyPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 03664897034325
Basic UDI-DI: 366489700083H9
Reference / catalog number: VKAXE12-080A3E-IT
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: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 30–165 MU29

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

V080701ACTIVE ANTI-DECUBITUS MEDICAL MATTRESSES

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

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