Identity
- Device Name
- Ardo Pumpset EUDAMED
- Model / Reference
- 63.00.53 EUDAMED63.00.52 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00814079021718 EUDAMED00814079021695 EUDAMED
- Basic UDI-DI
- B-00814079021718 EUDAMEDB-00814079021695 EUDAMED
- EMDN Code
- V020301 MANUAL BREAST PUMPERS AND KITS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
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
Ardo Pumpset 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-00814079021718 | 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 0ad7a8d2-3562-41aa-bab4-e7f809e95b6c 61 fields · synced Oct 6, 2026
- EUDAMED ecc2a3ad-7c1c-435d-966f-29591dc057ab 61 fields · synced May 18, 2026