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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

Micromate — Class I MDR by iSYS Medizintechnik GmbH

MD Atlas
iSYS Medizintechnik GmbH

EUDAMED last updated this device on Apr 20, 2023

Micromate

9010279iONE7K

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: iSYS Medizintechnik GmbH
UDI-DI code: 09010279000275
Reference / catalog number: 41206

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Manufacturer information

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

Critical warnings

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

CW010
EUDAMED did not publish a description for this code.
CW027
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Austria; available across 3 countries total.

Country	On market since	Until
AustriaPrimary placement		Still on market
EL		Still on market
Italy		Still on market

Device identification

Trade name: Micromate
UDI-DI code: 09010279000275
Basic UDI-DI: 9010279iONE7K
Reference / catalog number: 41206
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: The Micromate™ is a positioning and guidance system intended for the spatial positioning and orientation of instrument holders or tool guides to be used to hold and guide standard instruments, based on a pre-operative, operative (real time) plan and feedback from an image-guided navigation system or trajectory planning station with two–dimensional, three-dimensional imaging software and real time imaging.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z12011401SURGICAL NAVIGATION SYSTEM

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

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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.