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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

EPTEV02DEV01 — Class IIa MDR by IONCLINICS & DEIONIC,…

MD Atlas
IONCLINICS & DEIONIC, S.L.

EUDAMED last updated this device on Jul 27, 2023

EPTEV02DEV01

8437023158EPTEV02LQ

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: IONCLINICS & DEIONIC, S.L.
UDI-DI code: 08437023158012
Reference / catalog number: EPTEV02DEV01

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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	Jul 3, 2023	Still on market

Device identification

Trade name: not provided
UDI-DI code: 08437023158012
Basic UDI-DI: 8437023158EPTEV02LQ
Reference / catalog number: EPTEV02DEV01
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)

Z12062899NEUROMUSCULAR STIMULATION EQUIPMENT - OTHER

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

EPTEV02DEV028437023158EPTEV02LQOn the market EPTEV01DEV018437023158EPTEV01LNOn the market EPTEV01DEV028437023158EPTEV01LNOn 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.