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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

SEC4752 — Class I MDR by Pamel d.o.o.

MD Atlas
Pamel d.o.o.

EUDAMED last updated this device on Aug 17, 2023

SEC4752

385889415STANDARDEEGCAPFM

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Pamel d.o.o.
UDI-DI code: 03858894153121
Reference / catalog number: SEC4752

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Manufacturer information

Organization name: Pamel d.o.o.
SRN: HR-MF-000028336
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 Croatia; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: 03858894153121
Basic UDI-DI: 385889415STANDARDEEGCAPFM
Reference / catalog number: SEC4752
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: EEG cap for ELECTRODES FIXATION for EEG, EP or NEUROFEEDBACK, electrodes supplied separately
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 42–47 MU10

EMDN nomenclature code(s)

N01010203EEG HEADSETS

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

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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.