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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

EBV-AERO — Class I MDR by EGO Zlín, spol. s r.o.

MD Atlas
EGO Zlín, spol. s r.o.

EUDAMED last updated this device on Feb 12, 2026

EBV-AERO

859420647F01EBV6L

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: EGO Zlín, spol. s r.o.
UDI-DI code: 08594206470290
Reference / catalog number: EBV-AERO

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Manufacturer information

Organization name: EGO Zlín, spol. s r.o.
SRN: CZ-MF-000031911
Manufacturer status: Active

Market distribution

Primary placement in Czechia; available across 1 country total.

Placed on the market in Czechia; per-country availability dates not published.

Device identification

Trade name: not provided
UDI-DI code: 08594206470290
Basic UDI-DI: 859420647F01EBV6L
Reference / catalog number: EBV-AERO
Issuing entity: GS1

Classification

Risk category: Class I
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Biovak je mobilní izolační prostředek, který slouží k leteckému transportu osoby infikované vysoce nebezpečnou nákazou nebo osoby, u které je nezbytné zajistit ochranu před vnějším prostředím
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

T030599HEALTH SERVICE PREMISES PROTECTION 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

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Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.