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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

Ventica Electrodes — Class I MDR by Icare Finland Oy

MD Atlas
Icare Finland Oy

EUDAMED last updated this device on Nov 23, 2021

Ventica Electrodes

643003385IPEL0138

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Icare Finland Oy
UDI-DI code: 06430033850879
Reference / catalog number: IPEL01

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Manufacturer information

Organization name: Icare Finland Oy
SRN: FI-MF-000000501
Manufacturer status: Active

Critical warnings

3 warnings recorded — scroll inside the panel to see all entries.

CW010
EUDAMED did not publish a description for this code.
CW009
EUDAMED did not publish a description for this code.
CW007
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Finland; available across 1 country total.

Placed on the market in Finland; per-country availability dates not published.

Device identification

Trade name: Ventica Electrodes
UDI-DI code: 06430033850879
Basic UDI-DI: 643003385IPEL0138
Reference / catalog number: IPEL01
Issuing entity: GS1

Classification

Risk category: Class I
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://www.ventica.net/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z12159085VAROUS PNEUMOLOGY AND RESPIRATORY PHYSIOPATHOLOGY INSTRUMENTS - CONSUMABLES

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

iCare PATIENT2643003385TS057XOn the market Ventica Shirt, 90-100 cm643003385IPCL012SOn the market iCare CLINIC643003385TS027ROn the market iCare EXPORT643003385TS037TOn the market iCare HOME2643003385TA023XCOn 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.