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

HEKA Bes — Class I MDR by Challenge APS

MD Atlas
Challenge APS

EUDAMED last updated this device on Apr 14, 2026

HEKA Bes

57000022786HekaBesWK

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Challenge APS
UDI-DI code: 05700002278609
Reference / catalog number: HekaBes

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: Challenge APS
SRN: DK-MF-000035625
Manufacturer status: Active

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW999
Not for use in emergency or crisis intervention. Contraindicated for patients with active suicidal ideation, acute psychosis, or severe cognitive impairments. Not intended for use by individuals under 18 years of age. Not intended for standalone use, only to be used by trained professionals.

Market distribution

Primary placement in Denmark; available across 1 country total.

Country	On market since	Until
DenmarkPrimary placement		Still on market

Device identification

Trade name: HEKA Bes
UDI-DI code: 05700002278609
Basic UDI-DI: 57000022786HekaBesWK
Reference / catalog number: HekaBes
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: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Y214224AUGMENTATIVE SOFTWARE

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

This device is not currently linked to any other device.

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.