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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

3AU2020/2 — IVDR Class A IVDR by ABD SRL

MD Atlas
ABD SRL

EUDAMED last updated this device on Sep 27, 2023

3AU2020/2

8058945153AU2020/2E9

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: ABD SRL
UDI-DI code: 08058945155035
Reference / catalog number: 3AU2020/2

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View device family (Basic UDI)

Manufacturer information

Organization name: ABD SRL
SRN: IT-MF-000029729
Manufacturer status: Active

Related devices

3AU3001A8058945153AU3001AAWOn the market 3AU3001G8058945153AU3001GBAOn the market 3AU3001G38058945153AU3001G3GLOn the market 3AU3001M8058945153AU3001MBNOn the market 5N3001G28058945155N3001G25TOn 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

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

CW010
EUDAMED did not publish a description for this code.
CW007
EUDAMED did not publish a description for this code.
CW032
EUDAMED did not publish a description for this code.

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Market distribution

Primary placement in Italy; available across 2 countries total.

Country	On market since	Until
ItalyPrimary placement	Apr 29, 2021	Dec 31, 2099
Romania	Apr 29, 2021	Dec 31, 2099

Device identification

Trade name: not provided
UDI-DI code: 08058945155035
Basic UDI-DI: 8058945153AU2020/2E9
Reference / catalog number: 3AU2020/2
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: Control DNA/HIS/NUC IgG
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)08058945155035

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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.

W0102152011CONTROLS FOR AUTOIMMUNITY

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

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