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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

O.10.65 — IVDR Class A IVDR by Microbiol S.r.l.

MD Atlas
Microbiol S.r.l.

EUDAMED last updated this device on Apr 21, 2026

O.10.65

8057920RAPIDTESTQY

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: Microbiol S.r.l.
UDI-DI code: 08057920721036
Reference / catalog number: O.10.65

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View device family (Basic UDI)

Manufacturer information

Organization name: Microbiol S.r.l.
SRN: IT-MF-000052547
Manufacturer status: Active

Related devices

14.0685V8057920MEDIAPLATE906049On the market M.10.518057920RAPIDTESTQYOn the market 14.0012V8057920MEDIAPLATE906049On the market 18.0343-18057920TESTUBEMICROBIOLTBOn the market 14.0174V8057920MEDIAPLATE906049On 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

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 Italy; available across 1 country total.

Country	On market since	Until
ItalyPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 08057920721036
Basic UDI-DI: 8057920RAPIDTESTQY
Reference / catalog number: O.10.65
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: —
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)08057920721036

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UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

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EMDN nomenclature code(s)

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

W0105011201STAPHYLOCOCCAL DIRECT ANTIGEN DETECTION

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

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