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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

GM-B8 XL — Class I MDR by PATELLA-96 Kereskedelmi…

MD Atlas
PATELLA-96 Kereskedelmi és Szolgáltató Korlátolt Felelősségű Társaság

EUDAMED last updated this device on Apr 13, 2022

GM-B8 XL

599954297GM0931QH

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: PATELLA-96 Kereskedelmi és Szolgáltató Korlátolt Felelősségű Társaság
UDI-DI code: 05999542974137
Reference / catalog number: GM-B8 XL

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Manufacturer information

Organization name: PATELLA-96 Kereskedelmi és Szolgáltató Korlátolt Felelősségű Társaság
SRN: HU-MF-000004588
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 1 country total.

Placed on the market in Hungary; per-country availability dates not published.

Device identification

Trade name: not provided
UDI-DI code: 05999542974137
Basic UDI-DI: 599954297GM0931QH
Reference / catalog number: GM-B8 XL
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: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Y060308LUMBOSACRAL SPINE ORTHOSES

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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