EUDAMED last updated this device on Jun 7, 2023

W150596

842695055313783

On the marketIVDR Class B

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: Instrumentation Laboratory SpA
UDI-DI code: 08426950553137
Reference / catalog number: W150596

W150596 is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class B. Manufactured by Instrumentation Laboratory SpA. Placed on the EU market in Italy. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.

Role
Country
Date of registration
Address

EUDAMED last updated this device on Jun 7, 2023

W150596

842695055313783

On the marketIVDR Class B

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: Instrumentation Laboratory SpA
UDI-DI code: 08426950553137
Reference / catalog number: W150596

View device family (Basic UDI)

Device identification

Trade name: not provided
UDI-DI code: 08426950553137
Basic UDI-DI: 842695055313783
Reference / catalog number: W150596
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: DRI Methadone
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)08426950553137

UDI-PI DataMatrix

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

EMDN nomenclature code(s)

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

W0102090110METHADONE

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW010
EUDAMED did not publish a description for this code.

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

Certificates covering this device

No certificate specifically references this device's Basic UDI-DI.

Market distribution

Primary placement in Italy; available across 17 countries total.

Country	On market since	Until
ItalyPrimary placement	Jun 7, 2023	Still on market
Austria	Jun 7, 2023	Still on market
Belgium	Jun 7, 2023	Still on market
Cyprus	Jun 7, 2023	Still on market
Germany	Jun 7, 2023	Still on market
EL	Jun 7, 2023	Still on market
Spain	Jun 7, 2023	Still on market
Croatia	Jun 7, 2023	Still on market
Ireland	Jun 7, 2023	Still on market
Liechtenstein	Jun 7, 2023	Still on market
Lithuania	Jun 7, 2023	Still on market
Luxembourg	Jun 7, 2023	Still on market
Malta	Jun 7, 2023	Still on market
Netherlands	Jun 7, 2023	Still on market
Poland	Jun 7, 2023	Still on market
Romania	Jun 7, 2023	Still on market
XI	Jun 7, 2023	Still on market

Device identification

Trade name: not provided
UDI-DI code: 08426950553137
Basic UDI-DI: 842695055313783
Reference / catalog number: W150596
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: DRI Methadone
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

Manufacturer information

Organization name: Instrumentation Laboratory SpA
SRN: IT-MF-000009277
Manufacturer status: Active

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)08426950553137

UDI-PI DataMatrix

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

EMDN nomenclature code(s)

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

W0102090110METHADONE

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW010
EUDAMED did not publish a description for this code.

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

Certificates

Certificate health across this manufacturer's portfolio.

V12 034483 0002Issued
Quality management systemNotified body: 0123Expiry: Oct 2, 2027

Certificates covering this device

No certificate specifically references this device's Basic UDI-DI.

All products by Instrumentation Laboratory SpA

Market distribution

Primary placement in Italy; available across 17 countries total.

Country	On market since	Until
ItalyPrimary placement	Jun 7, 2023	Still on market
Austria	Jun 7, 2023	Still on market
Belgium	Jun 7, 2023	Still on market
Cyprus	Jun 7, 2023	Still on market
Germany	Jun 7, 2023	Still on market
EL	Jun 7, 2023	Still on market
Spain	Jun 7, 2023	Still on market
Croatia	Jun 7, 2023	Still on market
Ireland	Jun 7, 2023	Still on market
Liechtenstein	Jun 7, 2023	Still on market
Lithuania	Jun 7, 2023	Still on market
Luxembourg	Jun 7, 2023	Still on market
Malta	Jun 7, 2023	Still on market
Netherlands	Jun 7, 2023	Still on market
Poland	Jun 7, 2023	Still on market
Romania	Jun 7, 2023	Still on market
XI	Jun 7, 2023	Still on market

W150596

W150596

Device identification

Classification

Device details

UDI-PI traceability

UDI-DI DataMatrix

UDI-PI DataMatrix

EMDN nomenclature code(s)

Critical warnings

Compliance flags

Safety

Regulatory

Lifecycle

Certificates covering this device

Market distribution

Related searches

Device identification

Classification

Device details

Manufacturer information

UDI-PI traceability

UDI-DI DataMatrix

UDI-PI DataMatrix

EMDN nomenclature code(s)

Critical warnings

Compliance flags

Safety

Regulatory

Lifecycle

Certificates

Certificates covering this device

Related devices

Market distribution

Related searches

Manufacturer information

Certificates

Related devices