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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

HELP v1.x.x — Class I MDR by NEXTEC medical GmbH

MD Atlas
NEXTEC medical GmbH

EUDAMED last updated this device on Feb 4, 2026

HELP v1.x.x

426070508MD-helpDiGA2579

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: NEXTEC medical GmbH
UDI-DI code: 04260705080141
Reference / catalog number: HELP v1.x.x

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Manufacturer information

Organization name: NEXTEC medical GmbH
SRN: DE-MF-000005572
Manufacturer status: Active

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 04260705080141
Basic UDI-DI: 426070508MD-helpDiGA2579
Reference / catalog number: HELP v1.x.x
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: HELP is a digital health application that supports self-management in patients with chronic pain. Based on a biopsychosocial approach to pain, the app integrates various concepts of modern pain research, including Pain Reprocessing Therapy (PRT) and Emotional Awareness and Expression Therapy (EAET). Patients are supported in actively changing the way they deal with pain and developing new coping strategies. The aim of the digital application is to reduce pain interference and intensity, strengthen self-efficacy and systematically break the cycle of pain and anxiety. This is achieved by providing patients with information on pain-related topics such as its development, maintenance, chronification and psychoeducation. The topics are presented clearly in the form of videos, audios, graphics and texts. HELP is designed for independent use and can be used to complement multimodal pain therapy or to provide support while waiting for treatment. The application is not intended for diagnosis or therapeutic decision-making and does not replace medical professionals.
Additional information URL: https://help-app.de/wp-content/uploads/2025/08/HELP-IFU-v01-00_clean.pdf
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

V92MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES

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.