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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

ISaF — Class IIb MDD by LfC spółka z…

MD Atlas
LfC spółka z ograniczoną odpowiedzialnością

EUDAMED last updated this device on Aug 7, 2025

ISaF

B-05902363107905

On the marketClass IIb

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: LfC spółka z ograniczoną odpowiedzialnością
UDI-DI code: 05902363107905
Reference / catalog number: 841DT-00351020

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View device family (Basic UDI)

Manufacturer information

Organization name: LfC spółka z ograniczoną odpowiedzialnością
SRN: PL-MF-000024898
Manufacturer status: Active

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Certificates

Certificate health across this manufacturer's portfolio.

1434-MDR-043/2025Issued
Quality management systemNotified body: 1434Expiry: Nov 6, 2030

Critical warnings

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

CW001
Do not resterilize
CW007
Do not use if package is damaged
CW009
Do not re-use
CW010
Consult instructions for use

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Market distribution

Primary placement in Poland; available across 1 country total.

Country	On market since	Until
PolandPrimary placement	Sep 2, 2018	Still on market

Device identification

Trade name: ISaF
UDI-DI code: 05902363107905
Basic UDI-DI: B-05902363107905
Reference / catalog number: 841DT-00351020
Issuing entity: GS1

Classification

Risk category: Class IIb
Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: —
Additional information URL: https://www.lfc.com.pl/
Clinical sizes: Total lenght 35mm, sacral part 10mm, hip part 20mm

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

EMDN nomenclature code(s)

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

P09070199SPINAL FUSION SYSTEMS - OTHER

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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