- Role
- Country
- Date of registration
- Address
CH-MF-000051517PelvicTool Home & Sport is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by Alonea AG. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on May 22, 2026
76499886264PelvicToolQ8Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)07649988626494
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
3 warnings recorded — scroll inside the panel to see all entries.
iÎntended for indoor use only. Do not use near other electronic devices; observe the minimum distance specified in the user manual. Do not use the device on broken, irritated or diseased skin. Do not insert the device into any body orifices.
Consult a doctor before using the PelvicTool Home & Sport if you have had spinal surgery, have a complex functional disorder in the pelvic region, have pelvic instability, or are unsure whether training is suitable for your health or medical condition.
Sterile
A sterile device is supplied free of viable micro-organisms — flagged so that it is handled, stored and used to preserve that sterile state.
Single-use device
A single-use device is intended to be used on one patient during a single procedure and then discarded — not reprocessed or reused.
Contains latex
A "contains latex" flag warns that a device contains natural rubber latex, which can trigger allergic reactions in sensitive patients.
CMR substance
A CMR flag warns that a device contains a substance that is carcinogenic, mutagenic or toxic to reproduction above a defined threshold.
Endocrine-disrupting substance
An endocrine-disruptor flag warns that a device contains a substance with endocrine-disrupting properties above a defined threshold.
Primary placement in Germany; available across 16 countries total.
| Country | On market since | Until |
|---|---|---|
| GermanyPrimary placement | Dec 20, 2024 | Still on market |
| Austria | Dec 20, 2024 | Still on market |
| Belgium | Jun 2, 2025 | Still on market |
| Denmark | Jun 2, 2025 | Still on market |
| Spain | Jun 2, 2025 | Still on market |
| Finland | Jun 2, 2025 | Still on market |
| France | Dec 20, 2024 | Still on market |
| Ireland | Jun 2, 2025 | Still on market |
| Italy | Dec 20, 2024 | Still on market |
| Liechtenstein | Dec 20, 2024 | Still on market |
| Luxembourg | Jun 2, 2025 | Still on market |
| Malta | Jun 2, 2025 | Still on market |
| Netherlands | Jun 2, 2025 | Still on market |
| Norway | Jun 2, 2025 | Still on market |
| Sweden | Jun 2, 2025 | Still on market |
| Türkiye | Jun 30, 2026 | Still on market |
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
07649988626494Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
76499886264PelvicToolQ8100-301-00UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
MDR risk classes
MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.
European Medical Device Nomenclature — the EU product classification assigned to this device.
U070399PELVIC FLOOR REHABILITATION DEVICES - OTHERThis device is not currently linked to any other device.
No certificate specifically references this device's Basic UDI-DI.
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.