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K5
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref C09090-01-99510(k) K162515
by COSMED Srl
Identity
- Trade Name
- K5 EUDAMED
- Device Name
- K5 EUDAMED
- Model / Reference
- C09090-01-99 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 18052400180461 EUDAMED
- Basic UDI-DI
- 805240018K5N4 EUDAMED
- Direct Marketing DI
- 18052400180461 EUDAMED
- 510(k) Number
- K162515 FDA 510(k)
- FDA Product Code
- BZC FDA 510(k)
- EMDN Code
- Z12050101 STRESS ANALYSIS SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.1880 FDA 510(k)
- Regulation Number
- 868.1880 FDA 510(k)
- Market of Registration
- Italy EUDAMED
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
K5 by COSMED Srl — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K162515 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 805240018K5N4 | Class IIa | Active |
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Manufacturer
- Manufacturer
- COSMED Srl
- EUDAMED SRN
- IT-MF-000023488
Sources (2)
- EUDAMED 813f4eca-58bb-4d58-8903-5d6674f637ea 61 fields · synced Aug 4, 2026
- FDA 510(k) K162515 24 fields · synced May 18, 2026