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

Z-Hb Confirm — IVDD — General IVDD by ZOVEC diagnostics GmbH

MD Atlas
ZOVEC diagnostics GmbH

EUDAMED last updated this device on Apr 2, 2026

Z-Hb Confirm

B-42625753901228

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: ZOVEC diagnostics GmbH
UDI-DI code: 42625753901228
Reference / catalog number: Z-Hb Confirm

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: ZOVEC diagnostics GmbH
SRN: DE-MF-000035393
Manufacturer status: Active

Related devices

Chromatographic Column (HPLC) Z-Hb ConfirmB-42625753901532On the market Daily Cleaners kitB-42625753900238On the market DETERGENTB-42625753904052On the market DILUENTB-42625753903994On the market DILUENTB-42625753904120On 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.

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement	Feb 13, 2022	Still on market

Device identification

Trade name: Z-Hb Confirm
UDI-DI code: 42625753901228
Basic UDI-DI: B-42625753901228
Reference / catalog number: Z-Hb Confirm
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: Z-Hb Confirm Hemoglobin Analyzer (HPLC)
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0201050201HIGH PERFORMANCE LIQUID CHROMATOGRAPHY SYSTEMS

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