Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ 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

α-Amylase — IVDD — General IVDD by Cypress Diagnostics

MD Atlas
Cypress Diagnostics

EUDAMED last updated this device on Mar 19, 2026

α-Amylase

B-05404035101452

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: Cypress Diagnostics
UDI-DI code: 05404035101452
Reference / catalog number: HBE03

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?

Manufacturer information

Organization name: Cypress Diagnostics
SRN: BE-MF-000000033
Manufacturer status: Active

Related devices

Acid solution54040351CY008-WSXQOn the market AlbuminB-05404035101209On the market Alkaline PhosphataseB-05404035101476On the market APTT (Act. Thromboplastine Time)B-05404035101636On the market ASOB-05404035101964On 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

1 warning recorded — scroll inside the panel to see all entries.

CW010
See IFU

Market distribution

Primary placement in Belgium; available across 1 country total.

Placed on the market in Belgium; per-country availability dates not published.

Device identification

Trade name: α-Amylase
UDI-DI code: 05404035101452
Basic UDI-DI: B-05404035101452
Reference / catalog number: HBE03
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: The Cypress Diagnostics kit α-Amylase is an in vitro diagnostic medical device intended to be used for the quantitative measurement of α-amylase in human serum or plasma. The device is not automated. The measurement of α-amylase is intended to be used to aid in the diagnosis and monitoring of pancreatitis (inflammation of the pancreas), in patient risk population. This kit is intended to be used by healthcare professionals in a laboratory-based testing environment. For in vitro diagnostic use only. For professional use only.
Additional information URL: https://www.diagnostics.be/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W01010107AMYLASE - TOTAL

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification