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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

KAPPA LIGHT CHAINS (FREE+BOUND) — IVDD — General IVDD

MD Atlas
BEN S.R.L. BIOCHEMICAL ENTERPRISE

EUDAMED last updated this device on Apr 15, 2024

KAPPA LIGHT CHAINS (FREE+BOUND)

B-08033622179092

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: BEN S.R.L. BIOCHEMICAL ENTERPRISE
UDI-DI code: 08033622179092
Reference / catalog number: E05Y0101

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View device family (Basic UDI)

Manufacturer information

Organization name: BEN S.R.L. BIOCHEMICAL ENTERPRISE
SRN: IT-MF-000021057
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: KAPPA LIGHT CHAINS (FREE+BOUND)
UDI-DI code: 08033622179092
Basic UDI-DI: B-08033622179092
Reference / catalog number: E05Y0101
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: DETERMINAZIONE QUANTITATIVA IMMUNOTURBIDIMETRICA delle CATENE LEGGERE KAPPA su URINA e SIERO
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)08033622179092

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EMDN nomenclature code(s)

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

W0102010109KAPPA AND LAMBDA CHAIN

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

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