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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

EIAgen Detect HIV Combo Kit — IVDD — Annex II List A IVDD

MD Atlas
ADALTIS SRL

EUDAMED last updated this device on May 6, 2026

EIAgen Detect HIV Combo Kit

B-++M52108131CB3

On the marketIVDD — Annex II List A

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: ADALTIS SRL
UDI-DI code: ++M52108131CB3
Reference / catalog number: 081311C / 081312C / 081315C

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View device family (Basic UDI)

Manufacturer information

Organization name: ADALTIS SRL
SRN: IT-MF-000028990
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 Hungary; available across 1 country total.

Country	On market since	Until
HungaryPrimary placement		Still on market

Device identification

Trade name: EIAgen Detect HIV Combo Kit
UDI-DI code: ++M52108131CB3
Basic UDI-DI: B-++M52108131CB3
Reference / catalog number: 081311C / 081312C / 081315C
Issuing entity: HIBCC

Classification

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

Device details

Quantity: 1
Additional product description: EIAgen Detect HIV Combo Kit 96 Tests (081311C) / EIAgen Detect HIV Combo Kit 192 Tests (081312C) EIAgen Detect HIV Combo Kit 480 Tests (081315C)
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

++M52108131CB3

DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.

EMDN nomenclature code(s)

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

W0105030404HIV MULTIPLE AG/AB COMBI TEST

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

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Related devices

EIAgen HCV Ab (v.4) KitB-++M52107106LGOn 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.