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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

- — Class I MDR by Pohl-Boskamp Digital…

MD Atlas
Pohl-Boskamp Digital Health GmbH

EUDAMED last updated this device on Nov 8, 2022

-

4262400320003M

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Pohl-Boskamp Digital Health GmbH
UDI-DI code: 04262400320003
Reference / catalog number: -

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Manufacturer information

Organization name: Pohl-Boskamp Digital Health GmbH
SRN: DE-MF-000004969
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: 04262400320003
Basic UDI-DI: 4262400320003M
Reference / catalog number: -
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: Kalmeda bietet eine medizinisch fundierte, individuelle Tinnitus-Therapie auf Rezept, die immer da ist, wenn Nutzer sie brauchen. Mit dem Übungsprogramm von Kalmeda lernen Nutzer, Schritt für Schritt den Tinnitus zu bewältigen und wieder mehr Ruhe ins Leben zu bringen.  Die Kalmeda Tinnitus-App kombiniert eine kognitive Verhaltenstherapie mit medizinischer Wissensvermittlung, akustischen Hilfen und Entspannungsübungen. Sie beruht auf langjährigen Erfahrungen in der Behandlung von Tinnitus und entspricht den Leitlinien der wissenschaftlichen Fachgesellschaften.  Die App wurde von HNO-Spezialisten und Psychologen entwickelt und ist als Medizinprodukt (DiGA) zugelassen.
Additional information URL: No additional information URL provided by the manufacturer.
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

-4262400320027PGOn 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.