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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

00011172 — Class IIa MDR by Barkey GmbH & Co. KG

MD Atlas
Barkey GmbH & Co. KG

EUDAMED last updated this device on Aug 8, 2023

00011172

4059201S-lineXX

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Barkey GmbH & Co. KG
UDI-DI code: 04059201003132
Reference / catalog number: 00011172

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Manufacturer information

Organization name: Barkey GmbH & Co. KG
SRN: DE-MF-000005854
Manufacturer status: Active

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Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW010
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Germany; available across 2 countries total.

Country	On market since	Until
GermanyPrimary placement	Aug 1, 2023	Still on market
Austria	Aug 1, 2023	Still on market

Device identification

Trade name: not provided
UDI-DI code: 04059201003132
Basic UDI-DI: 4059201S-lineXX
Reference / catalog number: 00011172
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: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 60 MU50
160 MU50
90 MU50
1.3 MU29

EMDN nomenclature code(s)

Z12019008BLOOD HEATERS

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

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.