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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

Codea ePCR v1.2 — Class IIa MDR by Vitec Codea Oy

MD Atlas
Vitec Codea Oy

EUDAMED last updated this device on Oct 28, 2024

Codea ePCR v1.2

64298301616Codea.ePCR5M

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Vitec Codea Oy
UDI-DI code: 06429830161608
Reference / catalog number: Codea ePCR v1.2

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Manufacturer information

Organization name: Vitec Codea Oy
SRN: FI-MF-000012142
Manufacturer status: Active

Market distribution

Primary placement in Finland; available across 1 country total.

Country	On market since	Until
FinlandPrimary placement	Oct 29, 2024	Still on market

Device identification

Trade name: not provided
UDI-DI code: 06429830161608
Basic UDI-DI: 64298301616Codea.ePCR5M
Reference / catalog number: Codea ePCR v1.2
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: —
Additional information URL: No additional information URL provided by the manufacturer.
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

This device is not currently linked to any other device.

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.