Identity
- Trade Name
- AKASI EUDAMED
- Device Name
- AKASI Calculator App (web version) EUDAMED
- Model / Reference
- TD-16 EUDAMED08430308132806 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08430308132806 EUDAMED
- Basic UDI-DI
- B-08430308132806 EUDAMED
- EMDN Code
- V92 MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Special Device Type
- -1192 EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Akasi by Polichem SA, Lussemburgo, succursale di Mendrisio — Class I — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08430308132806 | Class I | Active |
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Manufacturer
- Manufacturer
- Polichem SA, Lussemburgo, succursale di Mendrisio
- EUDAMED SRN
- CH-MF-000025294
- Authorised Representative
- Almirall S.A. ES-AR-000019145
Sources (1)
- EUDAMED 830d3638-0976-4e80-a472-5abb64e48312 61 fields · synced Aug 1, 2026