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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

1.3.9 — Class IIb MDR by The wellbeing services…

MD Atlas
The wellbeing services county of Southwest Finland

EUDAMED last updated this device on Apr 24, 2025

1.3.9

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: 06438270000002
Reference / catalog number: 1.3.9

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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	Apr 24, 2025	Still on market
Denmark	Apr 24, 2025	Still on market

Device identification

Trade name: not provided
UDI-DI code: 06438270000002
Basic UDI-DI: 64382700001PJ
Reference / catalog number: 1.3.9
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

Related devices

1.3.8B-06438270000002On the market 1.464382700001PJOn 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.