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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

Lifting belt / Leashing belt — Class I MDR by Sairex Ky

MD Atlas
Sairex Ky

EUDAMED last updated this device on Dec 8, 2022

Lifting belt / Leashing belt

64298107684207XA

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Sairex Ky
UDI-DI code: 06429810768391
Reference / catalog number: 4207

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Manufacturer information

Organization name: Sairex Ky
SRN: FI-MF-000016116
Manufacturer status: Inactive

Market distribution

Primary placement in Finland; available across 1 country total.

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

Device identification

Trade name: Lifting belt / Leashing belt
UDI-DI code: 06429810768391
Basic UDI-DI: 64298107684207XA
Reference / catalog number: 4207
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: A belt-like fabric device with grip handles for manually lifting, leashing or moving a patient safely and ergonomically. Washable. Re-usable.
Additional information URL: https://verkkokauppa.sairex.fi/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z12019010PATIENT TRANSFER SYSTEMS

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

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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.