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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

iFIX Fleece 5 — Class I MDR by iSYS Medizintechnik GmbH

MD Atlas
iSYS Medizintechnik GmbH

EUDAMED last updated this device on Sep 30, 2024

iFIX Fleece 5

9010279iFIX6V

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: iSYS Medizintechnik GmbH
UDI-DI code: 09010279000107
Reference / catalog number: 31618

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Manufacturer information

Organization name: iSYS Medizintechnik GmbH
SRN: AT-MF-000000275
Manufacturer status: Active

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Critical warnings

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

CW011
EUDAMED did not publish a description for this code.
CW010
EUDAMED did not publish a description for this code.
CW009
EUDAMED did not publish a description for this code.
CW007
EUDAMED did not publish a description for this code.
CW025
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Austria; available across 1 country total.

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

Device identification

Trade name: iFIX Fleece 5
UDI-DI code: 09010279000107
Basic UDI-DI: 9010279iFIX6V
Reference / catalog number: 31618
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: 50 mm
30 mm

EMDN nomenclature code(s)

V0804PATIENT IMMOBILISERS (in diagnostic or therapeutic procedures)

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

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.