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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

APNOLAB — Class I MDR by FCEA Innovation

MD Atlas
FCEA Innovation

EUDAMED last updated this device on Jul 9, 2025

APNOLAB

376042103APNOLABAF

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: FCEA Innovation
UDI-DI code: 03760421030006
Reference / catalog number: APNOLAB

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Manufacturer information

Organization name: FCEA Innovation
SRN: FR-MF-000048421
Manufacturer status: Active

Market distribution

Primary placement in France; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: 03760421030006
Basic UDI-DI: 376042103APNOLABAF
Reference / catalog number: APNOLAB
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: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

V92MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES

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

Related devices

This device is not currently linked to any other device.

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.