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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

Alpha Amylase - Biotecnica Systems — IVDD — General IVDD

MD Atlas
GIESSE DIAGNOSTICS SRL

EUDAMED last updated this device on Feb 20, 2026

Alpha Amylase - Biotecnica Systems

B-08053172972912

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: 08053172972912
Reference / catalog number: BT5501

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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

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: Alpha Amylase - Biotecnica Systems
UDI-DI code: 08053172972912
Basic UDI-DI: B-08053172972912
Reference / catalog number: BT5501
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: reagent - Biotecnica Systems for the quantitative determination of α-Amylase in serum, plasma and urine
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.

W01010107AMYLASE - TOTAL

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

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