Identity
- Trade Name
- AMARYLL EUDAMEDFDA UDI
- Generic Name
- Breast pump, manual FDA UDI
- Device Name
- Amaryll EUDAMEDManual Breast Pump (until stock runs out) will be replaced: Amaryll Start (Catalog Number: 63.00.191) FDA UDI
- Model / Reference
- 63.00.190 EUDAMEDFDA UDI
- Description
- Manual Breast Pump (until stock runs out) will be replaced: Amaryll Start (Catalog Number: 63.00.191) FDA UDI
Identifiers
- Catalog Number
- 63.00.190 FDA UDI
- Primary DI / UDI-DI
- 07640109053267 EUDAMED00814079020094 FDA UDI
- Basic UDI-DI
- B-07640109053267 EUDAMED
- FDA Product Code
- HGY FDA UDI
- EMDN Code
- Z12080303 BREAST PUMPS EUDAMED
- GMDN Term
- Breast pump, manual FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 884.5150 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- Not 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Amaryll 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
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-07640109053267 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-07640109053267 | 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 080ca482-3f70-458a-b823-2e245afd0f5d 61 fields · synced Jun 6, 2026
- FDA UDI 0386ddd0-743a-409c-9c39-ccdd5644f71b 37 fields · synced May 29, 2026