Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Partners Contact

Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

4197 — IVDD — General IVDD by GIESSE DIAGNOSTICS SRL

MD Atlas
GIESSE DIAGNOSTICS SRL

EUDAMED last updated this device on Feb 24, 2026

4197

B-08053172970536

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: 08053172970536
Reference / catalog number: 4197

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

View device family (Basic UDI)

Manufacturer information

Organization name: GIESSE DIAGNOSTICS SRL
SRN: IT-MF-000039031
Manufacturer status: Active

Related devices

AlbuminB-08053172970024On the market AlbuminB-08053172970000On the market AlbuminB-08053172970017On the market Alkaline Phosphatase - Biotecnica SystemsB-08053172972899On the market Alkaline Phosphatase (DGKC)B-08053172972868On the market

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.

EasyUDICompliance engine

Sponsored

Your devices, UDI-compliant — without drowning in regulation

EUDAMED-ready· UDI-enriched

Basic UDIUDI-DIUDI-PIAttributeDocument

Print-ready label

From your product file — no manual entry

Exclusive to MD Atlas usersClaim my −20% discount

by Made In Tracker

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: 08053172970536
Basic UDI-DI: B-08053172970536
Reference / catalog number: 4197
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 consisting of two reagents for the quantitative determination of γ-glutamyltransferase (γ-GT) in serum. Kinetic method (Szasz-Tris).
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.

W01010116GAMMA GLUTAMYLTRANSFERASE

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

Become a partner of MD Atlas