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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

ScanAfia X ICU L W — Class I MDR by Lojer Oy

MD Atlas
Lojer Oy

EUDAMED last updated this device on Jun 25, 2024

ScanAfia X ICU L W

643002193HB0001JH

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Lojer Oy
UDI-DI code: 06430021931979
Reference / catalog number: ScanAfia X ICU L W

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Manufacturer information

Organization name: Lojer Oy
SRN: FI-MF-000001639
Manufacturer status: Active

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW010
See IFU for warnings, cautions and instructions for correct use of the device

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: not provided
UDI-DI code: 06430021931979
Basic UDI-DI: 643002193HB0001JH
Reference / catalog number: ScanAfia X ICU L W
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)

V08060101HOSPITAL/HOME CARE ELECTRIC 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

Related devices

4040X643002193ET0005PQOn the market 4040XH643002193ET0006PSOn the market 4040XL643002193ET0004PNOn the market 4050X F643002193ET0007PUOn the market 4050X M643002193ET0007PUOn 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.