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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

FEMANEA v 1.0.x-ce — Class I MDR by PrehApp GmbH

MD Atlas
PrehApp GmbH

EUDAMED last updated this device on May 29, 2026

FEMANEA v 1.0.x-ce

426236678FEMANEAHY

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: PrehApp GmbH
UDI-DI code: 04262366780033
Reference / catalog number: FEMANEA v 1.0.x-ce

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View device family (Basic UDI)

Manufacturer information

Organization name: PrehApp GmbH
SRN: DE-MF-000006936
Manufacturer status: Active

Critical warnings

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

CW010
EUDAMED did not publish a description for this code.

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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: 04262366780033
Basic UDI-DI: 426236678FEMANEAHY
Reference / catalog number: FEMANEA v 1.0.x-ce
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: The digital health application FEMANEA is a therapeutic training program for patients with urinary incontinence. Patients are provided with individualized therapy content that is evidence-based and guideline-compliant for their own training and is adapted to the patients' individual needs based on the patient's information. In addition, an educational section offers medical knowledge articles.
Additional information URL: https://femanea.de/
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)04262366780033

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UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

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EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

Z12069092VARIOUS PHYSIOTHERAPY AND REHABILITATION INSTRUMENTS - MEDICAL DEVICE 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

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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.