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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 B IVDR by Progastrin Manufacturing

MD Atlas
Progastrin Manufacturing

EUDAMED last updated this device on Jul 18, 2024

DxL2

37603145500798

On the marketIVDR Class B

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: Progastrin Manufacturing
UDI-DI code: 03760314550048
Reference / catalog number: DxL2

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Manufacturer information

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

Critical warnings

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

CW010
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.
CW007
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.
CW397
EUDAMED did not publish a description for this code.
CW416
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.
CW459
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.

Market distribution

Primary placement in France; available across 1 country total.

Country	On market since	Until
FrancePrimary placement	Feb 22, 2022	Oct 31, 2023

Device identification

Trade name: not provided
UDI-DI code: 03760314550048
Basic UDI-DI: 37603145500798
Reference / catalog number: DxL2
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: IVD test for the quantitative measurement of hPG80 (circulating progastrin) in human EDTA plasma
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0102019099SPECIFIC PROTEINS - 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 DxL2376031455DXPG809ROn 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.