Identity
- Trade Name
- Alyssa Hands-Free to-go FDA UDI
- Generic Name
- Breast pump, electric FDA UDI
- Model / Reference
- 63.00.513 FDA UDI
Identifiers
- Catalog Number
- 63.00.513 FDA UDI
- Primary DI / UDI-DI
- 07640108051080 FDA UDI
- 510(k) Number
- K212773 FDA UDI
- FDA Product Code
- HGX FDA UDI
- GMDN Term
- Breast pump, electric FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.5160 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Breast pump, electricBreast pump support kit, reusable
Alyssa Hands-Free to-go by Ardo medical AG — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Breast pump support kit, reusable.
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- PNSMX Resupply kits — Medela LLC · Class II
- Hands-free Breast shields, 24mm — Medela LLC · Class II
- Spectra — Uzinmedicare Co., Ltd. · Class II
Cleared under the same submission
K212773 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Ardo medical AG
Sources (2)
- FDA UDI e877e1ba-b358-434e-b000-aa8be87843de 36 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 2, 2026