Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Contact

Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

iFIX Head Mask S — Class I MDR by iSYS Medizintechnik GmbH

MD Atlas
iSYS Medizintechnik GmbH

EUDAMED last updated this device on Jul 30, 2024

iFIX Head Mask S

9010279iFIX6V

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: iSYS Medizintechnik GmbH
UDI-DI code: 09010279000145
Reference / catalog number: 26105

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

Manufacturer information

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

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 Head Mask S
UDI-DI code: 09010279000145
Basic UDI-DI: 9010279iFIX6V
Reference / catalog number: 26105
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: Short-term patient stabilization device
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 325 MU50

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

Related devices

iFIX Arm Rest Tray9010279iFIX6VOn the market iFIX Canon Aquilion Adapter9010279iFIX6VOn the market 163049010279iFIX6VOn the market iFIX Fleece 59010279iFIX6VOn the market iFIX Fleece 509010279iFIX6VOn 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.