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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

80562097200122 — IVDD — General IVDD by ENGENOME srl

MD Atlas
ENGENOME srl

EUDAMED last updated this device on Oct 14, 2022

80562097200122

B-80562097200122

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: ENGENOME srl
UDI-DI code: 80562097200122
Reference / catalog number: 80562097200122

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View device family (Basic UDI)

Manufacturer information

Organization name: ENGENOME srl
SRN: IT-MF-000029171
Manufacturer status: Active

Critical warnings

No critical warnings reported for this device.

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Market distribution

Primary placement in Italy; available across 1 country total.

Placed on the market in Italy; per-country availability dates not published.

Device identification

Trade name: not provided
UDI-DI code: 80562097200122
Basic UDI-DI: B-80562097200122
Reference / catalog number: 80562097200122
Issuing entity: GS1

Classification

Risk category: IVDD — General
Applicable legislation: IVDD [Directive 98/79/EC 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)80562097200122

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EMDN nomenclature code(s)

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

W02079082VARIOUS GENERAL PURPOSE IVD INSTRUMENTS - SOFTWARE ACCESSORIES

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

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Related devices

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Certificates

Certificate health across this manufacturer's portfolio.

IQMS/00007/0v001Issued
Quality management systemNotified body: 2962Expiry: Feb 25, 2031