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Organization name
UDI-DI code
Reference / catalog number

5997229570054 — Class I MDR by Pharmatextil…

MD Atlas
Pharmatextil Gyógyászati Textilgyártó Kft

EUDAMED last updated this device on Oct 13, 2022

5997229570054

599722957WR

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Pharmatextil Gyógyászati Textilgyártó Kft
UDI-DI code: 05997229570054
Reference / catalog number: 5997229570054

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Manufacturer information

Organization name: Pharmatextil Gyógyászati Textilgyártó Kft
SRN: HU-MF-000004634
Manufacturer status: Active

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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.

Market distribution

Primary placement in Hungary; available across 2 countries total.

Country	On market since	Until
HungaryPrimary placement	Jan 1, 2012	Dec 31, 2099
Romania	Jan 1, 2012	Dec 31, 2099

Device identification

Trade name: not provided
UDI-DI code: 05997229570054
Basic UDI-DI: 599722957WR
Reference / catalog number: 5997229570054
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: joint support (ankle)
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: E

EMDN nomenclature code(s)

M030499ELASTIC BANDAGES, SUPPORT AND COMPRESSION - 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

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