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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

EPTEV01DEV02 — Class IIa MDR by IONCLINICS & DEIONIC,…

MD Atlas
IONCLINICS & DEIONIC, S.L.

EUDAMED last updated this device on Aug 28, 2024

EPTEV01DEV02

8437023158EPTEV01LN

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: IONCLINICS & DEIONIC, S.L.
UDI-DI code: 08437023158043
Reference / catalog number: EPTEV01DEV02

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Manufacturer information

Organization name: IONCLINICS & DEIONIC, S.L.
SRN: ES-MF-000020207
Manufacturer status: Active

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW010
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Spain; available across 1 country total.

Country	On market since	Until
SpainPrimary placement	Sep 6, 2024	Still on market

Device identification

Trade name: not provided
UDI-DI code: 08437023158043
Basic UDI-DI: 8437023158EPTEV01LN
Reference / catalog number: EPTEV01DEV02
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)

Z12101106NEUROLOGICAL STIMULATORS

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

EPTEV02DEV018437023158EPTEV02LQOn the market EPTEV02DEV028437023158EPTEV02LQOn the market EPTEV01DEV018437023158EPTEV01LNOn 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.