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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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Anti-Ki-67 — 6 UDI-DI variants, IVDR (DB Biotech, a.s.)

MD Atlas
DB Biotech, a.s.

Data from EUDAMED, last updated May 31, 2026

Anti-Ki-67

85850389DB318LE

6 UDI-DI variants

IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]IVDR Class C

Legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk class: IVDR Class C
Manufacturer: DB Biotech, a.s.

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Device characteristics

ReagentProfessional testingAnimal tissues / cells

Identity & classification

Basic UDI-DI: 85850389DB318LE
Device name: Anti-Ki-67
Device model: DB 318
Issuing agency: GS1
Legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk class: IVDR Class C
Version date: Mar 25, 2026

Manufacturer & authorised representative

Manufacturer

Name: DB Biotech, a.s.
SRN: SK-MF-000051838
Country: Slovakia
Email: dbbiotech@dbbiotech.com

Variants by status

UDI-DI variants

6 UDI-DI variants

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Export results

Applied filters

basicUdiUlid01KMJ68HN7HZJ2CB6PD69WHX7J

Format

Summary

29 columns included

Trade name
Basic UDI-DI
UDI-DI code
Risk category
Applicable legislation
Status
Organization name
SRN
Reference / catalog number
Additional product description
Intended medical purpose
Placed on the market (country)
Market info update date
Sterile
Single use
Contains latex
Reprocessed single-use
Direct marking
CMR substance
Endocrine disruptor
Annex XVI applicable
Sterilization
OEM applicable
EMDN codes
Last updated
Basic UDI-DI device name
Basic UDI-DI device model
Basic UDI-DI implantable
Basic UDI-DI reagent

DB 318-0.108585038904688
DB 318-RTU-1508585038904725
DB 318-108585038904718
DB 318-RTU-708585038904732
DB 318-0.508585038904701
DB 318-0.208585038904695