Identity
- Trade Name
- CALYPSO EUDAMED
- Device Name
- Calypso EUDAMED
- Model / Reference
- 63.00.195 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07640109053311 EUDAMED
- Basic UDI-DI
- B-07640109053311 EUDAMED
- 510(k) Number
- K150721 FDA 510(k)
- FDA Product Code
- HGX FDA 510(k)
- EMDN Code
- Z12080303 BREAST PUMPS EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 884.5160 FDA 510(k)
- Regulation Number
- 884.5160 FDA 510(k)
- Market of Registration
- Germany EUDAMED
- Advisory Committee
- Obstetrics/Gynecology 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
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
Calypso by Ardo medical AG — Class IIa — FDA_510K, MDD — 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/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K150721 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-07640109053311 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Ardo medical AG
- EUDAMED SRN
- CH-MF-000016526
- Authorised Representative
- ARDO medical GmbH DE-AR-000014440
Sources (2)
- EUDAMED 6e798e23-3d75-4540-92b1-c58c94c08373 61 fields · synced Jul 8, 2026
- FDA 510(k) K150721 24 fields · synced May 18, 2026