Pedi X-ray

Organization name

Medical Innovation Design MID AB

SRN

SE-MF-000053189

Manufacturer status

Active

Primary placement in Sweden; available across 10 countries total.

Trade name

Pedi X-ray

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

07350132810118

Basic UDI-DI

Basic UDI-DI

The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.

735013281AS09-01Q7

Reference / catalog number

25

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

GS1

Risk category

MDR risk classes

MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.

Class I

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

PediXray Astrid Art no: AS09-01 PediXray aid for X-rays of lungs, abdomens, etc. on small children. Max. 20kg (approx. 2-3 years) Frontal and lateral images of the child's lungs can be taken without having to change the child's position. Soft galon mattress under the child's back and imaginative motifs to look at.

Additional information URL

https://www.mid.nu/produkter/pedixray-astrid-art-nr-as09-01-blue

Clinical sizes

No clinical sizes registered for this device.

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

European Medical Device Nomenclature — the EU product classification assigned to this device.

• V0804PATIENT IMMOBILISERS (in diagnostic or therapeutic procedures)

• Class I medical devices in EUDAMED

No certificate specifically references this device's Basic UDI-DI.