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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

HELIOS 160 W — Class I MDR by FAE Famed Łódź S.A.

MD Atlas
FAE Famed Łódź S.A.

EUDAMED last updated this device on Sep 12, 2023

HELIOS 160 W

5904708713HELIOS160KC

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: FAE Famed Łódź S.A.
UDI-DI code: 05904708713130
Reference / catalog number: HELIOS 160 W

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View device family (Basic UDI)

Manufacturer information

Organization name: FAE Famed Łódź S.A.
SRN: PL-MF-000018775
Manufacturer status: Active

Related devices

HELIOS 160 C5904708713HELIOS160KCOn the market HELIOS 160 F5904708713HELIOS160KCOn the market HELIOS 160 FA5904708713HELIOS160KCOn the market HELIOS 160/160 C5904708713HELIOS160KCOn the market HELIOS 160/60 C5904708713HELIOS160KCOn 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.

Critical warnings

2 warnings recorded — scroll inside the panel to see all entries.

CW010
yes
CW018
yes

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Market distribution

Primary placement in Poland; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: 05904708713130
Basic UDI-DI: 5904708713HELIOS160KC
Reference / catalog number: HELIOS 160 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.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)05904708713130

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UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

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EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

Z12010701FIXED SCIALYTIC LAMPS

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

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