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Organization name
UDI-DI code
Reference / catalog number

GastroPanel® Unified — IVDD — General IVDD by Biohit Oyj

MD Atlas
Biohit Oyj

EUDAMED last updated this device on Aug 26, 2022

GastroPanel® Unified

B-06419587064000

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: Biohit Oyj
UDI-DI code: 06419587064000
Reference / catalog number: 606400

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Manufacturer information

Organization name: Biohit Oyj
SRN: FI-MF-000014642
Manufacturer status: Active

Critical warnings

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

CW999
Please, read the instructions for use of separate kits.

Market distribution

Primary placement in Finland; available across 1 country total.

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

Device identification

Trade name: GastroPanel® Unified
UDI-DI code: 06419587064000
Basic UDI-DI: B-06419587064000
Reference / catalog number: 606400
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: GastroPanel Unified test is intended for diagnosing H. pylori infection and atrophic gastritis (AG) from patients with dyspeptic symptoms or at risk to develop malignant cellular changes in stomach mucosa. In addition, GastroPanel Unified test aids in screening conditions that necessitate additional examination or treatment from healthy stomach mucosa. The test can be conducted either manually or automatically and is to be used by healthcare professionals. For in vitro diagnostic use.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W01021499MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER

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

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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.