Identity
- Trade Name
- ONE MUM PUMPSET 72 H D31 EUDAMED
- Device Name
- Ardo Pumpset EUDAMED
- Model / Reference
- 63.00.50 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07640109059726 EUDAMED
- Basic UDI-DI
- B-07640109059726 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
One Mum Pumpset 72 H D31 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 | K172067 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-07640109059726 | 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 44040a87-562d-4f7b-82af-14feefd25bb1 61 fields · synced Jun 19, 2026
- FDA 510(k) K172067 1 fields · synced May 18, 2026