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Organization name
UDI-DI code
Reference / catalog number

BCOPD1 — Class I MDR by Breathment GmbH

MD Atlas
Breathment GmbH

EUDAMED last updated this device on Nov 26, 2025

BCOPD1

++G558G558BCOPD10ZE

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Breathment GmbH
UDI-DI code: G558BCOPD10
Reference / catalog number: BCOPD1

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Manufacturer information

Organization name: Breathment GmbH
SRN: DE-MF-000036840
Manufacturer status: Active

Market distribution

Primary placement in Germany; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: G558BCOPD10
Basic UDI-DI: ++G558G558BCOPD10ZE
Reference / catalog number: BCOPD1
Issuing entity: HIBCC

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: Breathment is a digital health software based on the scientifically founded concept of pulmonary rehabilitation. Breathment combines different approaches that have proven to be particularly effective together. Breathment's therapy program consists of four different elements: Movement: Stretch and strength exercises tailored to patients' abilities and needs, with varying levels of difficulty. Knowledge: Interactive knowledge sessions with tips and tricks for managing the relevant disease well. Relaxation, breathing techniques, and exercises: Guided exercises that help control breathing, manage shortness of breath, and support airway clearance. Collection of data: Health parameters are collected in the form of a patient diary, alongside activity tracking (e.g. daily step count), self-evaluation, and training performance data. Individualized therapy begins with an onboarding interview conducted by a physiotherapist to assess the patient’s physical fitness and specific needs. Based on the patient’s input and the diagnosis provided by the responsible doctor, the physiotherapist develops a personalized training plan. Patients also have access to standard programs.
Additional information URL: https://breathment.com/assets/pdfs/ifu-app.pdf%20https://breathment.com/assets/pdfs/ifu-myclinic.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

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.