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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

BT0018 — IVDD — General IVDD by GIESSE DIAGNOSTICS SRL

MD Atlas
GIESSE DIAGNOSTICS SRL

EUDAMED last updated this device on Feb 24, 2026

BT0018

B-08053172972592

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: GIESSE DIAGNOSTICS SRL
UDI-DI code: 08053172972592
Reference / catalog number: BT0018

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View device family (Basic UDI)

Manufacturer information

Organization name: GIESSE DIAGNOSTICS SRL
SRN: IT-MF-000039031
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

5 warnings recorded — scroll inside the panel to see all entries.

CW096
EUDAMED did not publish a description for this code.
CW137
EUDAMED did not publish a description for this code.
CW167
EUDAMED did not publish a description for this code.
CW313
EUDAMED did not publish a description for this code.
CW138
EUDAMED did not publish a description for this code.

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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: not provided
UDI-DI code: 08053172972592
Basic UDI-DI: B-08053172972592
Reference / catalog number: BT0018
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: diagnostic kit - Biotecnica Systems consisting of two reagents for the quantitative determination of creatine kinase, CK, in serum and plasma.
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.

W01010113CREATINE KINASE - TOTAL

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

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