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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

Washable PMMA reaction cuvette B — IVDR Class A IVDR

MD Atlas
Edif Instruments S.r.l.

EUDAMED last updated this device on Nov 9, 2023

Washable PMMA reaction cuvette B

805360894CML07018GS

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: 80536089443088
Reference / catalog number: CML07018A-001B

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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: Washable PMMA reaction cuvette B
UDI-DI code: 80536089443088
Basic UDI-DI: 805360894CML07018GS
Reference / catalog number: CML07018A-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 reaction cuvette CML07018A-001B is an IVD consumable intended to be used multiple times in analytical units for incubation and photometric absorbance measurements of reaction mixtures. The washing of the cuvette should be performed automatically by the device.
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)80536089443088

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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.

W0201010185CHEMISTRY ANALYSERS - CONSUMABLES
W0201020185AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

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