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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

zh016/10/en/01_RFU — Class IIb MDR by ЖИВАС ООД

MD Atlas
ЖИВАС ООД

EUDAMED last updated this device on Oct 10, 2025

zh016/10/en/01_RFU

38002282401654

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: ЖИВАС ООД
UDI-DI code: 03800228243480
Reference / catalog number: zh016/10/en/01_RFU

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Manufacturer information

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

Related devices

zh013/5/en/013800228240134WOn the market Oxiultra3800228240134WOn the market zh042/10/bg/01_50%38002282404255On the market zh024/4/bg/0138002282402453On the market zh042/5/bg/01_50%38002282404255On the market

Market distribution

Primary placement in Bulgaria; available across 1 country total.

Country	On market since	Until
BulgariaPrimary placement	Oct 26, 2011	Nov 10, 2028

Device identification

Trade name: not provided
UDI-DI code: 03800228243480
Basic UDI-DI: 38002282401654
Reference / catalog number: zh016/10/en/01_RFU
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)

D0902ASSOCIATED AMMONIUM SALTS FOR THE DISINFECTION OF MEDICAL DEVICES

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