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Organization name
UDI-DI code
Reference / catalog number

1.3.8 — Class IIa MDD by The wellbeing services…

MD Atlas
The wellbeing services county of Southwest Finland

EUDAMED last updated this device on Jun 19, 2024

1.3.8

B-06438270000002

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: The wellbeing services county of Southwest Finland
UDI-DI code: 06438270000002
Reference / catalog number: 1.3.8

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Manufacturer information

Organization name: The wellbeing services county of Southwest Finland
SRN: FI-MF-000038025
Manufacturer status: Active

Market distribution

Primary placement in Finland; available across 2 countries total.

Country	On market since	Until
FinlandPrimary placement		Still on market
Denmark		Still on market

Device identification

Trade name: not provided
UDI-DI code: 06438270000002
Basic UDI-DI: B-06438270000002
Reference / catalog number: 1.3.8
Issuing entity: GS1

Classification

Risk category: Class IIa
Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: —
Additional information URL: https://turkupetcentre.fi/_carimas/files/ce/ifu/v1_3_8/fi/Index.html?page=Main
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z11020492POSITRON EMISSION TOMOGRAPHY INSTRUMENTS - MEDICAL DEVICE SOFTWARE

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

1.464382700001PJOn the market 1.3.964382700001PJOn the market

Certificates

Certificate health across this manufacturer's portfolio.

CR-03-1220-858-24Supplemented
Quality management systemNotified body: 0537Expiry: Nov 25, 2029