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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

Alluminum adapter for reagent cup… — IVDR Class A IVDR

MD Atlas
Edif Instruments S.r.l.

EUDAMED last updated this device on Dec 21, 2022

Alluminum adapter for reagent cup or tube on 30 positions reagent tray (100 mm height)

805360894ACC07028/29/33D8

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: 80536089410936
Reference / catalog number: ACC07033A-001C

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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: Alluminum adapter for reagent cup or tube on 30 positions reagent tray (100 mm height)
UDI-DI code: 80536089410936
Basic UDI-DI: 805360894ACC07028/29/33D8
Reference / catalog number: ACC07033A-001C
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 adapter ACC07033B-001C is an IVD accessory intended to be used in analytical units to place a cup or a tube in a reagent position.
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

EMDN nomenclature code(s)

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

W0201020180AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HARDWARE ACCESSORIES
W0201010180CHEMISTRY ANALYSERS - HARDWARE ACCESSORIES

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

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