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Organization name
UDI-DI code
Reference / catalog number

1.4 — Class IIb MDR by The wellbeing services…

MD Atlas
The wellbeing services county of Southwest Finland

Manufacturer information

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

Certificates

Certificate health across this manufacturer's portfolio.

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

EUDAMED last updated this device on Apr 17, 2026

1.4

64382700001PJ

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: The wellbeing services county of Southwest Finland
UDI-DI code: 06438270000019
Reference / catalog number: 1.4

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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 1 country total.

Country	On market since	Until
FinlandPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 06438270000019
Basic UDI-DI: 64382700001PJ
Reference / catalog number: 1.4
Issuing entity: GS1

Classification

Risk category: Class IIb
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: —
Additional information URL: https://carimas.fi/carimasce/
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

Certificates

Certificate health across this manufacturer's portfolio.

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

Manufacturer information

Certificates

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1.4

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UDI-PI traceability

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