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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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Oncobit PM GNA11Q209 — 2 UDI-DI variants, IVDR (Oncobit AG)

MD Atlas
Oncobit AG

Data from EUDAMED, last updated May 23, 2026

Oncobit PM GNA11Q209

7649995954PMGNA11Q20935

2 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: Oncobit AG

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Device characteristics

ReagentProfessional testing

Identity & classification

Basic UDI-DI: 7649995954PMGNA11Q20935
Device name: Oncobit PM GNA11Q209
Device model: 1.0
Issuing agency: GS1
Legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk class: IVDR Class C
Version date: Jan 7, 2025

Manufacturer & authorised representative

Manufacturer

Name: Oncobit AG
SRN: CH-MF-000037436
Country: Switzerland
Email: claudia.scheckel@oncobit.com

Authorised representative

Name: MedEnvoy Global BV
SRN: NL-AR-000024028
Country: Netherlands
Phone: +31 70 326 21 48

Variants by status

UDI-DI variants

2 UDI-DI variants

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Export results

Applied filters

basicUdiUlid01JH01VG8MWQ4R8J5B9JY6HPSX

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

PM-1-02-01-207649995954269
PM-1-02-01-107649995954252