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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

HEV IgM — IVDD — General IVDD by DIA.PRO DIAGNOSTIC…

MD Atlas
DIA.PRO DIAGNOSTIC BIOPROBES S.R.L.

EUDAMED last updated this device on May 21, 2026

HEV IgM

B-08050616040183

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: DIA.PRO DIAGNOSTIC BIOPROBES S.R.L.
UDI-DI code: 08050616040183
Reference / catalog number: EVM.CE

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View device family (Basic UDI)

Manufacturer information

Organization name: DIA.PRO DIAGNOSTIC BIOPROBES S.R.L.
SRN: IT-MF-000029123
Manufacturer status: Active

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Critical warnings

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

CW159
EUDAMED did not publish a description for this code.
CW166
EUDAMED did not publish a description for this code.
CW167
EUDAMED did not publish a description for this code.
CW193
EUDAMED did not publish a description for this code.
CW194
EUDAMED did not publish a description for this code.
CW422
EUDAMED did not publish a description for this code.
CW430
EUDAMED did not publish a description for this code.
CW444
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.
CW306
EUDAMED did not publish a description for this code.
CW999
P310 - Immediately call a POISON CENTER or doctor/physician.
CW999
P363 - Wash contaminated clothing before reuse.
CW073
EUDAMED did not publish a description for this code.
CW081
EUDAMED did not publish a description for this code.
CW083
EUDAMED did not publish a description for this code.
CW106
EUDAMED did not publish a description for this code.
CW149
EUDAMED did not publish a description for this code.
CW066
EUDAMED did not publish a description for this code.

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Market distribution

Primary placement in Italy; available across 1 country total.

Country	On market since	Until
ItalyPrimary placement	Mar 1, 2004	Still on market

Device identification

Trade name: HEV IgM
UDI-DI code: 08050616040183
Basic UDI-DI: B-08050616040183
Reference / catalog number: EVM.CE
Issuing entity: GS1

Classification

Risk category: IVDD — General
Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Enzyme Immunoassay (ELISA) for the determination of IgM antibodies to Hepatitis E Virus in human serum and plasma
Additional information URL: No additional information URL provided by the manufacturer.
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)08050616040183

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EMDN nomenclature code(s)

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

W0105020505HEV ANTIBODY IGM

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

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.