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Sign in to claim this brandBioWink GmbH
Germany·DE-MF-000030007
Last updated May 30, 2026
What BioWink GmbH makes
BioWink GmbH develops self‑care monitoring and reporting software, including the Clue family of applications such as Clue Birth Control, Clue Conceive, and the general Clue app.
The software portfolio is regulated under Class I, Class II, and U device classifications and is listed in the EUDAMED database as well as the FDA 510(k) and FDA UDI registries; the company is based in Germany.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What does BioWink GmbH make?
BioWink GmbH develops self-care monitoring and reporting software, including the Clue family of applications such as Clue Birth Control, Clue Conceive, and the general Clue app, which are designed for personal health tracking and fertility awareness.
Where is BioWink GmbH based?
BioWink GmbH is based in Germany, as indicated by its country code DE in the device data, which confirms the company's location without implying any regulatory approval of the company itself.
Which regulatory registries list BioWink GmbH's devices?
BioWink GmbH's devices are listed in the EUDAMED database, the FDA 510(k) registry, and the FDA UDI registry, as explicitly stated in the device data under LISTED IN, reflecting where the devices are registered for market access.
How are BioWink GmbH's devices classified?
BioWink GmbH's devices are regulated under Class I, Class II, and U classifications, as specified in the DEVICE CLASSES field, indicating varying levels of regulatory control based on risk and intended use of the software applications.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- Germany
- Address
- 7-8, Adalbertstraße, Berlin, Germany
- Website
- www.helloclue.com
- —
- —
- [email protected]
- Phone
- —
- PRRC Contact
- Giulia Paggiola
- EUDAMED SRN
- DE-MF-000030007
- FDA FEI Number
- —
- DUNS Number
- 342751189
Catalogue (5)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Clue Birth Control | 1 | FDA UDI | Class II | Active |
| Clue Conceive | iOS | FDA UDI | U | Active |
| Clue Conceive | Android | FDA UDI | U | Active |
| Clue Birth Control | K193330 | EUDAMEDFDA 510(k)FDA UDI | Class II | Active |
| Clue | Clue (Android) | EUDAMEDFDA UDI | Class I | Active |
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