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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

2007 — IVDD — General IVDD by Diagnostics s.r.o.

MD Atlas
Diagnostics s.r.o.

EUDAMED last updated this device on Apr 10, 2026

2007

B-08588007926148

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: Diagnostics s.r.o.
UDI-DI code: 08588007926148
Reference / catalog number: 2007

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View device family (Basic UDI)

Manufacturer information

Organization name: Diagnostics s.r.o.
SRN: SK-MF-000038255
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 Slovakia; available across 1 country total.

Country	On market since	Until
SlovakiaPrimary placement	Jan 1, 2013	Still on market

Device identification

Trade name: not provided
UDI-DI code: 08588007926148
Basic UDI-DI: B-08588007926148
Reference / catalog number: 2007
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: INDOXYL je detekčným prúžkom pre detekciu acetátesterázovej aktivity. Detekčný prúžok vykazuje enzymatickú aktivitu tvorbu modrého až modro - zeleného sfarbenia na základe metabolizmu vyšetrovaných vzoriek. Detekční prúžok je používaný pre prezumptívnu identifikáciu Moraxella (B.) catarrhalis alebo diferenciáciu campylobakterov
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

UDI-DI DataMatrix

Encoded

(01)08588007926148

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EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

W0104080208SINGLE TESTS (DISCS, STRIPS, DROPPERS...)

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

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