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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

HB10005 — Class I MDR by LINEA One Kft.

MD Atlas
LINEA One Kft.

EUDAMED last updated this device on Feb 22, 2023

HB10005

5999131250116AY

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: LINEA One Kft.
UDI-DI code: 05999131200081
Reference / catalog number: HB10005

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Manufacturer information

Organization name: LINEA One Kft.
SRN: HU-MF-000028125
Manufacturer status: Active

Related devices

HB100045999131250116AYOn the market HB112005999131250116AYOn the market HB112015999131250116AYOn the market HB114075999131250116AYOn the market HB114065999131250116AYOn 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.

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: 05999131200081
Basic UDI-DI: 5999131250116AY
Reference / catalog number: HB10005
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)

V080603TREATMENT, DIAGNOSIS AND MONITORING MEDICAL BEDS

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