Identity
- Trade Name
- One Mum Pumpset D31 EUDAMEDOneMumPumpset D31 FDA UDI
- Generic Name
- Breast pump support kit, single-use FDA UDI
- Device Name
- Ardo Pumpset EUDAMEDThe Ardo Pumpset should be used in combination with Ardo breastpumps and is intended to be used by lactating women to express and collect milk from their breast. The Pumpset can be used both as a single pumpset and as a double pumpset and is intented for single users only. FDA UDI
- Model / Reference
- 63.00.125 EUDAMEDFDA UDI
- Description
- The Ardo Pumpset should be used in combination with Ardo breastpumps and is intended to be used by lactating women to express and collect milk from their breast. The Pumpset can be used both as a single pumpset and as a double pumpset and is intented for single users only. FDA UDI
Identifiers
- Catalog Number
- 63.00.125 FDA UDI
- Primary DI / UDI-DI
- 00814079021640 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00814079021640 EUDAMED
- 510(k) Number
- K172067 FDA UDI
- FDA Product Code
- HGX FDA UDI
- EMDN Code
- V020301 MANUAL BREAST PUMPERS AND KITS EUDAMED
- GMDN Term
- Breast pump support kit, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 884.5160 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
One Mum Pumpset D31 by Ardo medical AG — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00814079021640 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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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 90e886de-c14a-4bf0-8f6b-b8c400b41986 61 fields · synced Jun 19, 2026
- FDA UDI accbf23a-40ba-49ed-b17e-cfaaba183247 37 fields · synced May 29, 2026