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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

PROFIL'AIR — Class I MDR by RECFRANCE

MD Atlas
RECFRANCE

EUDAMED last updated this device on May 29, 2026

PROFIL'AIR

3666364MACOPRES8X

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: RECFRANCE
UDI-DI code: 03666364000246
Reference / catalog number: RECCPA002

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View device family (Basic UDI)

Manufacturer information

Organization name: RECFRANCE
SRN: FR-MF-000000820
Manufacturer status: Active

Critical warnings

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

CW010
EUDAMED did not publish a description for this code.

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Market distribution

Primary placement in France; available across 1 country total.

Country	On market since	Until
FrancePrimary placement		Still on market

Device identification

Trade name: PROFIL'AIR
UDI-DI code: 03666364000246
Basic UDI-DI: 3666364MACOPRES8X
Reference / catalog number: RECCPA002
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: Class I Medical Device - Series cushion for pressure sore prevention - Indicated for patients at high or very high risk of ischial pressure sores or with a maximum stage 1 pressure sore (presence of erythema) without stability disorder (single compartment) or with stability disorder (multi-compartment).
Additional information URL: https://recfrance.com/catalogue/
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)03666364000246

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UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

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EMDN nomenclature code(s)

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

V080399MEDICAL CUSHIONS - OTHER

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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Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.