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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

STD-045.2 — IVDD — General IVDD by BIOCLARMA S.R.L.

MD Atlas
BIOCLARMA S.R.L.

EUDAMED last updated this device on May 22, 2025

STD-045.2

B-08057723370233

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: BIOCLARMA S.R.L.
UDI-DI code: 08057723370233
Reference / catalog number: STD-045.2

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View device family (Basic UDI)

Manufacturer information

Organization name: BIOCLARMA S.R.L.
SRN: IT-MF-000030384
Manufacturer status: Active

Related devices

SQT-028B-08057723370042On the market STD-045B-08057723370219On the market STD-027B-08057723370004On the market SQTd-045.2B-08057723370196On the market SQTd-045.1B-08057723370189On 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.

Critical warnings

No critical warnings reported for this device.

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Market distribution

Primary placement in Italy; available across 3 countries total.

Country	On market since	Until
ItalyPrimary placement		Still on market
Czechia		Still on market
France		Still on market

Device identification

Trade name: not provided
UDI-DI code: 08057723370233
Basic UDI-DI: B-08057723370233
Reference / catalog number: STD-045.2
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: Standard for the Quantification of PML/RARa t(15;17) translocation, variant BCR2
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)08057723370233

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EMDN nomenclature code(s)

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

W01060299TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

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