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

Disposable Felt Tips for Handheld… — Class I MDR

MD Atlas
Natus Manufacturing Limited

EUDAMED last updated this device on May 2, 2024

Disposable Felt Tips for Handheld Bipolar Felt Pad Stimulating Electrode

0382830059152TZ

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Natus Manufacturing Limited
UDI-DI code: 00382830049559
Reference / catalog number: 9013L3522

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: Natus Manufacturing Limited
SRN: IE-MF-000000799
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 Ireland; available across 1 country total.

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

Device identification

Trade name: Disposable Felt Tips for Handheld Bipolar Felt Pad Stimulating Electrode
UDI-DI code: 00382830049559
Basic UDI-DI: 0382830059152TZ
Reference / catalog number: 9013L3522
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: Reusable Handheld Felt Pad Stimulating Electrodes are used to assess the propagation properties of normal and diseased nerves. Electrodes are expected to maintain a continuous connection for monitoring electromyogenic and physiologic data signals.
Additional information URL: https://natus.com/support/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

N010101ELECTROMYOGRAPHIC ELECTRODES

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

3-ch. EMG/EP Amplifier038283NA00166ENOn the market 6-ch. EMG/EP Amplifier038283NA00166ENOn the market 6-ch. EP Amplifier038283NA00166ENOn the market 8-ch. EMG/EP Amplifier038283NA00166ENOn the market Bo-ject DHN Disp Electrode, 1.5"(37mm)x0.41mm038283NA00007DZOn 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.