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EUDAMED last updated this device on Apr 22, 2026
739205910BPPFCCABIOpH+ Footcare is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by Biocool AB. Placed on the EU market in Sweden. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
07392059101573BPPFC250EU(01)07392059101573
European Medical Device Nomenclature — the EU product classification assigned to this device.
V9099VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER1 warning recorded — scroll inside the panel to see all entries.
Keep sealed, out of reach of children, at room temperature and away from inflammable substances. Avoid contact with eyes; in the event of contact with eyes, rinse with water for at least 10 minutes. In case of medical concern consult health care proffessional. For external use. Avoid contact with open wounds. - Keep out of reach of children, at room temperature and away from inflammable substances. - Use by pregnant and nursing females has not been tested and is therefore not recommended. - Do not use on open wounds, avoid contact with eyes, may cause irritation. In case of contact with eyes, rinse thoroughly with lukewarm water for at least 10 minutes. Wash hands thoroughly after handling. If severe skin or eye irritation occurs, consult healthcare professional. - Improper use or hypersensitivity to sodium percarbonate may cause skin irritation. - For external use on feet only. - May cause slippery feet/floors. Dry feet with a clean towel after treatment. - Do not use if the container is damaged or if the seal is missing on a new container. For safe opening of the lid, pull off the seal in the direction of the arrow.
SE-MF-00001241128620160593The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
Primary placement in Sweden; available across 6 countries total.
| Country | On market since | Until |
|---|---|---|
| SwedenPrimary placement | May 17, 2024 | May 17, 2090 |
| Germany | May 17, 2024 | May 17, 2090 |
| Denmark | May 17, 2024 | May 17, 2090 |
| Finland | May 17, 2024 | May 17, 2090 |
| France | Feb 2, 2026 | May 17, 2090 |
| Norway | May 17, 2024 | May 17, 2090 |
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.
View in glossary →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.
View in glossary →Contains latex
A "contains latex" flag warns that a device contains natural rubber latex, which can trigger allergic reactions in sensitive patients.
View in glossary →CMR substance
A CMR flag warns that a device contains a substance that is carcinogenic, mutagenic or toxic to reproduction above a defined threshold.
View in glossary →Endocrine-disrupting substance
An endocrine-disruptor flag warns that a device contains a substance with endocrine-disrupting properties above a defined threshold.
View in glossary →Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
View in glossary →UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
View in glossary →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.
View in glossary →Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →Certificate health across this manufacturer's portfolio.
28620160593IssuedNotified body
A notified body is an independent organisation, designated by an EU country, that audits manufacturers and certifies higher-risk devices before they can be CE-marked.
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