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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

DxL2 — IVDR Class C IVDR by Progastrin Manufacturing

MD Atlas
Progastrin Manufacturing

EUDAMED last updated this device on Apr 30, 2026

DxL2

376031455DXPG809R

On the marketIVDR Class C

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: Progastrin Manufacturing
UDI-DI code: 03760314550079
Reference / catalog number: DxL2

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Manufacturer information

Organization name: Progastrin Manufacturing
SRN: FR-MF-000011162
Manufacturer status: Active

Critical warnings

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

CW010
EUDAMED did not publish a description for this code.
CW009
EUDAMED did not publish a description for this code.
CW007
EUDAMED did not publish a description for this code.
CW032
EUDAMED did not publish a description for this code.
CW266
EUDAMED did not publish a description for this code.
CW043
EUDAMED did not publish a description for this code.
CW076
EUDAMED did not publish a description for this code.
CW082
EUDAMED did not publish a description for this code.
CW083
EUDAMED did not publish a description for this code.
CW085
EUDAMED did not publish a description for this code.
CW159
EUDAMED did not publish a description for this code.
CW162
EUDAMED did not publish a description for this code.
CW163
EUDAMED did not publish a description for this code.
CW165
EUDAMED did not publish a description for this code.
CW167
EUDAMED did not publish a description for this code.
CW296
EUDAMED did not publish a description for this code.
CW422
EUDAMED did not publish a description for this code.
CW416
EUDAMED did not publish a description for this code.
CW397
EUDAMED did not publish a description for this code.
CW361
EUDAMED did not publish a description for this code.
CW360
EUDAMED did not publish a description for this code.
CW373
EUDAMED did not publish a description for this code.
CW305
EUDAMED did not publish a description for this code.
CW306
EUDAMED did not publish a description for this code.
CW304
EUDAMED did not publish a description for this code.
CW452
EUDAMED did not publish a description for this code.
CW999
P501: Dispose of contents and containers to a waste approved for hazardous products, in accordance with local, national and/or international regulations.

Market distribution

Primary placement in France; available across 1 country total.

Country	On market since	Until
FrancePrimary placement	Apr 30, 2026	Still on market

Device identification

Trade name: not provided
UDI-DI code: 03760314550079
Basic UDI-DI: 376031455DXPG809R
Reference / catalog number: DxL2
Issuing entity: GS1

Classification

Risk category: IVDR Class C
Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Quantification of hPG80 (circulating progastrin) in EDTA human plasma as an aid to diagnosis and prognosis of cancer
Additional information URL: https://www.biodenacare.com/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0102030199CANCER ANTIGENS - OTHER

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

DxL437603145500798On the market DxL237603145500798On the market

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.