Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Partners 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

Enbio S (P-EU) — 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 (P-EU)

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: 59041656640208
Reference / catalog number: Enbio S (P-EU)

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?

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.

EasyUDICompliance engine

Sponsored

Your devices, UDI-compliant — without drowning in regulation

EUDAMED-ready· UDI-enriched

Basic UDIUDI-DIUDI-PIAttributeDocument

Print-ready label

From your product file — no manual entry

Exclusive to MD Atlas usersClaim my −20% discount

by Made In Tracker

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: 59041656640208
Basic UDI-DI: 5904165sterylizatoryE2
Reference / catalog number: Enbio S (P-EU)
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 Dolly Pink (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

Become a partner of MD Atlas