Identity
- Trade Name
- DOUBLE PUMPSET EUDAMEDFDA UDI
- Generic Name
- Breast pump support kit, reusable 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
- 63.00.223 EUDAMED63.00.222 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
- 63.00.222 FDA UDI
- Primary DI / UDI-DI
- 07640109053588 EUDAMED07640109053571 EUDAMED00814079020933 FDA UDI
- Basic UDI-DI
- B-07640109053588 EUDAMEDB-07640109053571 EUDAMED
- 510(k) Number
- K141742 FDA UDI
- FDA Product Code
- HGX FDA UDI
- EMDN Code
- Z12080385 VARIOUS CHILDBIRTH SUPPORT AND MATERNAL ASSISTANCE INSTRUMENTS - CONSUMABLES EUDAMED
- GMDN Term
- Breast pump support kit, reusable 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
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Double Pumpset 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-07640109053588 | 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 (3)
- EUDAMED e03d6dc3-0b64-468b-b731-a3332149f46c 61 fields · synced Jul 22, 2026
- EUDAMED 608888a7-d21d-432a-a076-13a905fe654e 61 fields · synced May 19, 2026
- FDA UDI b8add8bd-eb5d-4805-8b29-880c33d1b66a 37 fields · synced May 30, 2026