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Organization name
UDI-DI code
Reference / catalog number

446010133300 — Class IIa MDR by Hagleitner Hygiene…

MD Atlas
Hagleitner Hygiene International GmbH

EUDAMED last updated this device on Mar 1, 2023

446010133300

9008353114219L

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Hagleitner Hygiene International GmbH
UDI-DI code: 09008353114215
Reference / catalog number: 446010133300

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Manufacturer information

Organization name: Hagleitner Hygiene International GmbH
SRN: AT-MF-000023685
Manufacturer status: Active

Market distribution

Primary placement in Austria; available across 3 countries total.

Country	On market since	Until
AustriaPrimary placement		Still on market
Germany		Still on market
Italy		Still on market

Device identification

Trade name: not provided
UDI-DI code: 09008353114215
Basic UDI-DI: 9008353114219L
Reference / catalog number: 446010133300
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: No clinical sizes registered for this device.

EMDN nomenclature code(s)

D050199ASSOCIATED PERACETIC ACID FOR THE DISINFECTION OF MEDICAL 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

Related devices

N.B4.14.01.01 / 4460101433069008353114219LOn the market 1701627900835321984BGOn the market 445030454255900835321984BGOn the market 445030454200900835321984BGOn the market 445030440000900835321979BPOn the market

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.