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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

Floats and tubes modular… — IVDR Class A IVDR

MD Atlas
Edif Instruments S.r.l.

EUDAMED last updated this device on Dec 21, 2022

Floats and tubes modular connection for ES00001

805360894ACC010095A

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: 80536089405390
Reference / catalog number: ACC01009A-001B

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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: Floats and tubes modular connection for ES00001
UDI-DI code: 80536089405390
Basic UDI-DI: 805360894ACC010095A
Reference / catalog number: ACC01009A-001B
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 float and tubes modular connection ACC01009A-001A is an IVD accessory intended to be used in analytical units to monitor liquid tank levels and provide the hydraulic connection between the tanks and the analyzer.
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)80536089405390

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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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