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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

Enbio S — Class IIa MDR by Enbio Technology Sp. z…

MD Atlas
Enbio Technology Sp. z o. o.

EUDAMED last updated this device on Nov 21, 2023

Enbio S

5904165sterylizatoryE2

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Enbio Technology Sp. z o. o.
UDI-DI code: 59041656640512
Reference / catalog number: Enbio S

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View device family (Basic UDI)

Manufacturer information

Organization name: Enbio Technology Sp. z o. o.
SRN: PL-MF-000024063
Manufacturer status: Active

Related devices

Enbio SB-59041656640062On the market Enbio S5904165sterylizatoryE2On the market Enbio S5904165sterylizatoryE2On the market Enbio PRO5904165sterylizatoryE2On the market Enbio S5904165sterylizatoryE2On the market

Certificates

Certificate health across this manufacturer's portfolio.

TNP/MDR/0047/4332/2026Reissued
Quality management systemNotified body: 2274Expiry: Feb 5, 2029
TNP/MDR/0007/4332/2023Issued
Quality management systemNotified body: 2274Expiry: Feb 5, 2026

Critical warnings

No critical warnings reported for this device.

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Market distribution

Primary placement in Poland; available across 1 country total.

Country	On market since	Until
PolandPrimary placement	Mar 1, 2023	Still on market

Device identification

Trade name: not provided
UDI-DI code: 59041656640512
Basic UDI-DI: 5904165sterylizatoryE2
Reference / catalog number: Enbio S
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: Enbio S Yellow Sunflower (230V) (Polish and EU plug)
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

Z12011305SMALL LOAD AUTOCLAVES WITH A CHAMBER SMALLER THAN 1 STANDARD STERILISATION UNIT

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

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