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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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Zhivasept OPA — 2 UDI-DI variants, MDR (ЖИВАС ООД)

MD Atlas
ЖИВАС ООД

Data from EUDAMED, last updated May 23, 2026

Zhivasept OPA

38002282405258

2 UDI-DI variants

MDR [Regulation (EU) 2017/745 on medical devices]Class IIb

Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class IIb
Manufacturer: ЖИВАС ООД

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Device characteristics

No device characteristics flagged

Legacy certificates

Certificate number: 2023-MDR/QS-057
Type: refdata.certificate-mdr-type.quality-management-system
Notified body: 3EC International a.s. (2265)
Validity: Dec 1, 2023 → Dec 1, 2028

Identity & classification

Basic UDI-DI: 38002282405258
Device name: Zhivasept OPA
Issuing agency: GS1
Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class IIb
Version date: Jan 16, 2024

Manufacturer & authorised representative

Manufacturer

Name: ЖИВАС ООД
SRN: BG-MF-000019745
Country: Bulgaria
Email: zhivas@techno-link.com
Phone: +35929817823

Variants by status

UDI-DI variants

2 UDI-DI variants

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Applied filters

basicUdiUlid01HM97RH7NKQ74ZQ185D8MTPEX

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

zh052/5000/bg/0103800228243657
zh/052/4000/bg/0103800228243664