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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

300 — Class I MDR by AURIMOD GmbH

MD Atlas
AURIMOD GmbH

EUDAMED last updated this device on Sep 6, 2022

300

9120112973006K

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: AURIMOD GmbH
UDI-DI code: 9120112973007
Reference / catalog number: 300

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Manufacturer information

Organization name: AURIMOD GmbH
SRN: AT-MF-000000433
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.
CW007
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: not provided
UDI-DI code: 9120112973007
Basic UDI-DI: 9120112973006K
Reference / catalog number: 300
Issuing entity: HIBCC

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: Needle Applicator is intended for use only in combination with VIVO by qualified medical personnel in professional healthcare environments to facilitate the mounting and placement of the VIVO needle electrodes in the auricle of the patient by a mechanical mechanism.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

V0880MEDICAL SUPPORT EQUIPMENT - ACCESSORIES

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

10091201129710069On the market 2009120112972006EOn the market 100B-09120112971003On 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.