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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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Enbio S — 1 UDI-DI variant, MDD (Enbio Technology Sp. z o. o.)

MD Atlas
Enbio Technology Sp. z o. o.

Data from EUDAMED, last updated May 30, 2026

Enbio S

B-59041656640062

1 UDI-DI variant

MDD [Directive 93/42/EEC on medical devices]Class IIb

Legislation: MDD [Directive 93/42/EEC on medical devices]
Risk class: Class IIb
Manufacturer: Enbio Technology Sp. z o. o.

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Device characteristics

Active device

Legacy certificates

Certificate number: TNP/MDD/0279/4332/2019
Type: refdata.legacy.mdd-certificate-type.ii-excluding-4
Notified body: TUV NORD Polska Sp. z o.o (2274)
Validity: Sep 28, 2022

Identity & classification

Basic UDI-DI: B-59041656640062
Device name: Enbio S
Device model: Enbio S
Issuing agency: EUDAMED
Legislation: MDD [Directive 93/42/EEC on medical devices]
Risk class: Class IIb
Special device type: refdata.special-mdd-device-type.software
Version date: Jun 10, 2022

Manufacturer & authorised representative

Manufacturer

Name: Enbio Technology Sp. z o. o.
SRN: PL-MF-000024063
Country: Poland
Email: lukasz.rogowski@enbio.com

Variants by status

UDI-DI variants

1 UDI-DI variant

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Applied filters

basicUdiUlid01G56EVGT4CZ6G68CGDDYRKV5H

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

Enbio S59041656640062