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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

5N3004ML 16ml — IVDR Class A IVDR by ABD SRL

MD Atlas
ABD SRL

EUDAMED last updated this device on Sep 26, 2023

5N3004ML 16ml

8058945155N3004ML8E

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: 08058945155844
Reference / catalog number: 5N3004ML 16ml

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View device family (Basic UDI)

Manufacturer information

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

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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: 08058945155844
Basic UDI-DI: 8058945155N3004ML8E
Reference / catalog number: 5N3004ML 16ml
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: Substrate/Chromogen
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)08058945155844

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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.

W01029003BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

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