Biocool AB
Active in EUDAMEDSwedenfrom SRN EUDAMED SRN SE-MF-000012411
- Devices
- 5
- Registrations
- EUDAMED
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
What Biocool AB makes
Biocool AB manufactures medical foot baths and bath products designed for psoriasis treatment, including the BIOpH+ Medical foot bath, BIOpH+ Psoriasis medical bath, and Almirall MyFungar Medizinisches Fußbad. The company also produces the BIOpH+ Footcare line, intended for foot hygiene and care.
These devices fall under EU Class IIa classification and are registered in the EUDAMED database. The company is based in Sweden.
Catalogue
BIOpH+ Psoriasis medical bath Ref 1000002
Regimes: CE MDR Registry: EUDAMEDBIOpH+ Medical foot bath Ref 1000008
Regimes: CE MDR Registry: EUDAMEDBIOpH+ Psoriasis medical bath Ref 1000001
Regimes: CE MDR Registry: EUDAMEDAlmirall MyFungar Medizinisches Fußbad Ref 10000012
Regimes: CE MDR Registry: EUDAMEDBIOpH+ Footcare Ref BPPFC500EU
Regimes: CE MDR Registry: EUDAMED
Company details
- EUDAMED SRN
- SE-MF-000012411
- EU VAT number
- SE556884-820301
- EUDAMED status
- Active
- EUDAMED registered name
- Biocool AB
- Registered address
- 39, Malmskillnadsgatan, 102 14, Stockholm, Sweden
- Website
- biophplus.com/
- facebook.com/BIOpHplus
- [email protected]
- PRRC contact
- Maria Lindgren
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 5 Oct 2028
Intertek Medical Notified Body AB 2862 1 certificate
- 28620160593 Active
Quality management system EU MDR
- Issued
- 26 Oct 2023
- Expires
- 5 Oct 2028
From the company website
BIOpH+ offers gentle, simple and effective foot, skin and facial care products — Proven effective, as well as simple in their design and use.
Frequently asked questions
How many devices does Biocool AB have in the registry?
The registry currently lists 5 devices for Biocool AB. Devices recorded under merged duplicate company entries are counted once.
Which registries list Biocool AB's devices?
Among its 5 most recently registered devices, Biocool AB has devices listed in EUDAMED (5 devices).
What risk classes do Biocool AB's devices fall under?
Among its 5 most recently registered devices, the classes recorded for Biocool AB's devices are Class IIa. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for Biocool AB?
EUDAMED lists 1 certificate for Biocool AB (quality management system) under MDR. 1 is recorded with the status issued. The most recent was issued on 26 Oct 2023.
What are the newest devices from Biocool AB in the registry?
The most recently registered devices listed for Biocool AB include BIOpH+ Psoriasis medical bath, BIOpH+ Medical foot bath, Almirall MyFungar Medizinisches Fußbad and BIOpH+ Footcare.