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

100222209 — Class I MDR by Humanelektronik GmbH

MD Atlas
Humanelektronik GmbH

EUDAMED last updated this device on Aug 24, 2023

100222209

426076432HEKOMMUNLIGHT2JB

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Humanelektronik GmbH
UDI-DI code: 04260764320042
Reference / catalog number: 100222209

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: Humanelektronik GmbH
SRN: DE-MF-000013990
Manufacturer status: Active

Related devices

10021041s426076432HESeeTech6COn the market 954426076432HESeeTech6COn the market 402105426076432HESeeTech6COn the market 2669426076432HESeeTech6COn the market 10021044426076432HESeeTech6COn 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.

Market distribution

Primary placement in Germany; available across 3 countries total.

Country	On market since	Until
GermanyPrimary placement		Still on market
Austria		Still on market
Netherlands		Still on market

Device identification

Trade name: not provided
UDI-DI code: 04260764320042
Basic UDI-DI: 426076432HEKOMMUNLIGHT2JB
Reference / catalog number: 100222209
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: Hilfsmittel zur unterstützten Kommunikation mit Touchscreen
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Y214209ALPHABETIC AND SYMBOLIC COMMUNICATORS

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