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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

AI-00002894 — Class I MDR by HUS-yhtymä

MD Atlas
HUS-yhtymä

EUDAMED last updated this device on May 24, 2024

AI-00002894

6438300ASQDV

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: HUS-yhtymä
UDI-DI code: 06438300000033
Reference / catalog number: AI-00002894

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Manufacturer information

Organization name: HUS-yhtymä
SRN: FI-MF-000007401
Manufacturer status: Active

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW999
Screening of ASD symptoms in children younger than < 16 months, older than > 30 months, adults, adolescents. Not intended to be used for diagnosing ASD or making treatment decis

Market distribution

Primary placement in Finland; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: 06438300000033
Basic UDI-DI: 6438300ASQDV
Reference / catalog number: AI-00002894
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: Autism screening questionnaire is intended for screening of autism spectrum disorder (ASD) symptoms and assessing the risk of ASD in a child aged 16-30 months. It is a digitalized version of previously validated M-CHAT-R/FTM questionnaire.
Additional information URL: https://www.terveyskyla.fi/lastentalo/tietoa-lasten-sairauksista/autismikirjon-hairiot/autismikirjon-hairion-seulontakysely
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

V92MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES

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

AI-000019576438300OPU3On the market AI-000029606438300OPU3On 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.