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Ardo Bellis
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref 63.00.522Ref 63.00.521Ref 63.00.523
Identity
- Trade Name
- Ardo Bellis EUDAMED
- Device Name
- Ardo Bellis EUDAMED
- Model / Reference
- 63.00.522 EUDAMED63.00.521 EUDAMED63.00.523 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07640108051486 EUDAMED07640108051462 EUDAMED07640108051493 EUDAMED
- Basic UDI-DI
- B-07640108051486 EUDAMEDB-07640108051462 EUDAMEDB-07640108051493 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
Ardo Bellis 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 | K230590 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-07640108051486 | 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 (4)
- EUDAMED 54d97c62-0541-4c9b-b449-09a747845379 61 fields · synced Oct 6, 2026
- EUDAMED 15f98c97-12a7-4ca2-9a6d-6d1da07b70f5 61 fields · synced May 18, 2026
- EUDAMED e2c7a217-2373-4d47-8f68-b32742169fd2 61 fields · synced May 18, 2026
- FDA 510(k) K230590 1 fields · synced May 18, 2026