Identity
- Trade Name
- Calypso Conversion Kit EUDAMED
- Device Name
- Calypso EUDAMED
- Model / Reference
- 63.00.248 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07640109053809 EUDAMED
- Basic UDI-DI
- B-07640109053809 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 Conversion Kit 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-07640109053809 | 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 (1)
- EUDAMED 3f69472b-88ef-4dfe-931c-02db9649cb2f 61 fields · synced Jul 12, 2026