Identity
- Trade Name
- CALYPSO DOUBLE PLUS EUDAMED
- Device Name
- Calypso EUDAMED
- Model / Reference
- 63.00.197 EUDAMED63.00.198 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07640109053335 EUDAMED07640109053342 EUDAMED
- Basic UDI-DI
- B-07640109053335 EUDAMEDB-07640109053342 EUDAMED
- EMDN Code
- Z12080303 BREAST PUMPS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
Calypso Double Plus by Ardo medical AG — Class IIa — 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-07640109053335 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ardo medical AG
- EUDAMED SRN
- CH-MF-000016526
- Authorised Representative
- ARDO medical GmbH DE-AR-000014440
Sources (2)
- EUDAMED b94b076b-056f-4ea5-9e75-42dc3d856d35 61 fields · synced Jul 15, 2026
- EUDAMED c43f226a-9e60-43db-9d84-f8203a92088a 61 fields · synced May 18, 2026