Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Contact

Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

Bypass electrodes Ag/AgCl — Class I MDR by Pamel d.o.o.

MD Atlas
Pamel d.o.o.

EUDAMED last updated this device on Jul 11, 2023

Bypass electrodes Ag/AgCl

385889415EEGELECTRODESHC

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Pamel d.o.o.
UDI-DI code: 03858894153398
Reference / catalog number: BYP10

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

Manufacturer information

Organization name: Pamel d.o.o.
SRN: HR-MF-000028336
Manufacturer status: Active

Related devices

Adapter cable 20/25/1,5mm / EEG0385889415ADAPTERCABLE97On the market Adapter cable 20/25/1,5mm /EEG SIGMA0385889415ADAPTERCABLE97On the market Adapter cable 21/25/1,5mm / EEG0385889415ADAPTERCABLE97On the market Adapter cable 23/25/1,5mm / EEG0385889415ADAPTERCABLE97On the market Adapter cable 24/25/1,5mm / EEG0385889415ADAPTERCABLE97On 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.

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: Bypass electrodes Ag/AgCl
UDI-DI code: 03858894153398
Basic UDI-DI: 385889415EEGELECTRODESHC
Reference / catalog number: BYP10
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: Bypass electrodes Ag/AgCl
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

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