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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

Kit Accessories QCA Bio 100 — IVDR Class A IVDR

MD Atlas
Edif Instruments S.r.l.

EUDAMED last updated this device on Dec 21, 2022

Kit Accessories QCA Bio 100

805360894ACC0710067

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: Edif Instruments S.r.l.
UDI-DI code: 80536089417652
Reference / catalog number: ACC07201G-001A

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View device family (Basic UDI)

Manufacturer information

Organization name: Edif Instruments S.r.l.
SRN: IT-MF-000009556
Manufacturer status: Active

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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

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: Kit Accessories QCA Bio 100
UDI-DI code: 80536089417652
Basic UDI-DI: 805360894ACC0710067
Reference / catalog number: ACC07201G-001A
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: The ACC07201G-001A kit of accessories is an IVD accessory including all required hardware accessories required to operate the analytical unit ES00004-AV6.
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
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Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)80536089417652

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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.

W0201010180CHEMISTRY ANALYSERS - HARDWARE ACCESSORIES
W0201020180AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HARDWARE ACCESSORIES

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

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