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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

DB 318-1 — IVDR Class C IVDR by DB Biotech, a.s.

MD Atlas
DB Biotech, a.s.

EUDAMED last updated this device on Apr 9, 2026

DB 318-1

85850389DB318LE

On the marketIVDR Class C

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: DB Biotech, a.s.
UDI-DI code: 08585038904718
Reference / catalog number: DB 318-1

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View device family (Basic UDI)

Manufacturer information

Organization name: DB Biotech, a.s.
SRN: SK-MF-000051838
Manufacturer status: Active

Related devices

DB 147-0.185850389DB147LBOn the market DB 147-RTU-785850389DB147LBOn the market DB 147-RTU-1585850389DB147LBOn the market DB 147-0.585850389DB147LBOn the market DB 147-185850389DB147LBOn 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

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		Still on market

Device identification

Trade name: not provided
UDI-DI code: 08585038904718
Basic UDI-DI: 85850389DB318LE
Reference / catalog number: DB 318-1
Issuing entity: GS1

Classification

Risk category: IVDR Class C
Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: —
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.

W01030705FIXING REAGENTS (HISTOLOGY/CYTOLOGY)

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

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