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Organization name
UDI-DI code
Reference / catalog number

FEMNA Care — Class I MDR by FEMNA Health M.E. GmbH

MD Atlas
FEMNA Health M.E. GmbH

EUDAMED last updated this device on Aug 15, 2024

FEMNA Care

426055034FEMC4Y

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: FEMNA Health M.E. GmbH
UDI-DI code: 04260550340001
Reference / catalog number: FEMC001

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Manufacturer information

Organization name: FEMNA Health M.E. GmbH
SRN: DE-MF-000042215
Manufacturer status: Inactive

Critical warnings

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

CW999
Inclusion criteria: - Completed 16 years of age - Exclusion of pregnancy - Diagnosis made or symptom duration of at least 3 months

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: FEMNA Care
UDI-DI code: 04260550340001
Basic UDI-DI: 426055034FEMC4Y
Reference / catalog number: FEMC001
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: FEMNA Care offers an education and training platform for women aged 16 and over and primarily addresses the topic of women's health and associated possible diseases and symptoms, such as endometriosis, PMS, PCO, dysmenorrhea. The software solution qualifies as therapy support, adapted to the woman's clinical picture, with an interface to experts from recognized health professions. The aim is to create awareness of your own illness so that you can deal with it better in everyday life and thereby increase your quality of life - despite cycle-related symptoms.
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

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.