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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

LBM Selenite — IVDR Class A IVDR by Copan Italia S.P.A.

MD Atlas
Copan Italia S.P.A.

EUDAMED last updated this device on May 26, 2026

LBM Selenite

80533260CD0380AM004BZ

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: Copan Italia S.P.A.
UDI-DI code: 08053326004551
Reference / catalog number: 4E021N.A

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View device family (Basic UDI)

Manufacturer information

Organization name: Copan Italia S.P.A.
SRN: IT-MF-000022535
Manufacturer status: Active

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Certificates

Certificate health across this manufacturer's portfolio.

G10 073936 0018Issued
Quality management systemNotified body: 0123Expiry: Feb 12, 2028
V11 073936 0015Issued
Quality management systemNotified body: 0123Expiry: Apr 18, 2027

Critical warnings

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

CW009
EUDAMED did not publish a description for this code.
CW010
EUDAMED did not publish a description for this code.
CW011
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: LBM Selenite
UDI-DI code: 08053326004551
Basic UDI-DI: 80533260CD0380AM004BZ
Reference / catalog number: 4E021N.A
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: BROTH FOR AUTOMATION 2 mL ROUND TUBE
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)08053326004551

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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.

W050301020101SAMPLES ANALYSES, PLASTIC TUBES WITH ADDITIVES

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

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