Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Contact

Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

Oxiultra — Class IIb MDR by ЖИВАС ООД

MD Atlas
ЖИВАС ООД

EUDAMED last updated this device on Aug 18, 2025

Oxiultra

3800228240134W

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: ЖИВАС ООД
UDI-DI code: 03800228240465
Reference / catalog number: zh013/1/en/01

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

Manufacturer information

Organization name: ЖИВАС ООД
SRN: BG-MF-000019745
Manufacturer status: Active

Related devices

zh013/5/en/013800228240134WOn the market zh042/10/bg/01_50%38002282404255On the market zh024/4/bg/0138002282402453On the market zh042/5/bg/01_50%38002282404255On the market zh024/1/bg/0138002282402453On the market

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW010
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Bulgaria; available across 2 countries total.

Country	On market since	Until
BulgariaPrimary placement		Nov 10, 2028
Latvia		Nov 10, 2028

Device identification

Trade name: Oxiultra
UDI-DI code: 03800228240465
Basic UDI-DI: 3800228240134W
Reference / catalog number: zh013/1/en/01
Issuing entity: GS1

Classification

Risk category: Class IIb
Applicable legislation: MDR [Regulation (EU) 2017/745 on 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.

EMDN nomenclature code(s)

D0599OXYGEN PRODUCERS FOR DISINFECTION OF MEDICAL DEVICES - OTHER

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Certificates

Certificate health across this manufacturer's portfolio.

2026-MDR/QS-025Issued
Quality management systemNotified body: 2265Expiry: Nov 10, 2028
2025-MDR/QS-047Issued
Quality management systemNotified body: 2265Expiry: Nov 10, 2028
2025-MDR/QS-043Issued
Quality management systemNotified body: 2265Expiry: Aug 15, 2028
2024-MDR/QS-063Issued
Quality management systemNotified body: 2265Expiry: Nov 8, 2029
2024-MDR/QS-062Issued
Quality management systemNotified body: 2265Expiry: Nov 8, 2029
2023-MDR/QS-057

Issued

Quality management systemNotified body: 2265Expiry: Dec 1, 2028