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Sign in to claim this brandWILLOW INNOVATIONS, INC.
United States·US-MF-000050199
Last updated May 24, 2026
What WILLOW INNOVATIONS, INC. makes
Willow Innovations, Inc. manufactures electric and manual breast pumps, including rechargeable and single-use models, as well as reusable support kits for lactation. Their product line also includes silicone nipple inserts, single-use nipple pads, milk storage bags, and replacement components like chargers, tubing sets, and container inserts designed for compatibility with their pumps.
The company’s devices are regulated under FDA 510(k) and UDI listings in the U.S., with some products also registered in the EU via EuDAMED. These products fall under Class I and Class II classifications, depending on their intended use and risk level.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Willow Innovations, Inc. manufacture?
Willow Innovations, Inc. specializes in breastfeeding support devices, including electric and manual breast pumps, reusable support kits, and accessories. Their product line covers silicone nipple inserts, single-use nipple pads, milk storage bags, and replacement components like chargers, tubing sets, and container inserts. These devices are designed to assist with lactation and milk expression.
Where is Willow Innovations, Inc. based?
Willow Innovations, Inc. is headquartered in the United States. Their product line is developed and manufactured within this region, adhering to applicable regulatory standards.
Which regulatory registries list Willow Innovations, Inc.’s devices?
Willow Innovations, Inc.’s devices are listed in multiple regulatory databases, including the FDA’s 510(k) and UDI registries in the U.S. Additionally, some of their products are registered in the EU via EuDAMED. These listings reflect compliance with respective regulatory requirements for medical devices.
How are Willow Innovations, Inc.’s devices classified under medical device regulations?
Willow Innovations, Inc.’s devices are classified under Class I and Class II categories, depending on their intended use and associated risk levels. For example, reusable components like pumps and support kits may fall under Class II due to their direct contact with the body and functional complexity, while accessories like single-use nipple pads may qualify as Class I due to lower risk. Classification determines regulatory oversight and submission requirements.
Why are some of Willow Innovations, Inc.’s devices registered in EuDAMED?
EuDAMED is the EU’s medical device registry, used to track devices marketed within the European Economic Area. Willow Innovations, Inc. registers devices in EuDAMED when they are intended for sale or use in the EU, ensuring compliance with EU Medical Device Regulations (MDR) or In Vitro Diagnostic Regulation (IVDR). Registration confirms the device meets EU safety, performance, and traceability standards before entering the market.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- United States
- Address
- 1975, West El Camino Real, Mountain View, United States
- Website
- onewillow.com
- —
- —
- [email protected]
- Phone
- —
- PRRC Contact
- An Nguyen
- EUDAMED SRN
- US-MF-000050199
- FDA FEI Number
- —
- DUNS Number
- 050917861
Catalogue (106)
Page 2 of 3| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Elvie Pump | 01 | FDA UDI | Class II | Active |
| Willow Go Pump Accessory Diaphragms (2 pk) | LPD270 | FDA UDI | Class II | Active |
| Container Accessory Kit, 27 mm x 2 | C2739 | FDA UDI | Class II | Active |
| Wave, Flange 24mm, Replacement | RF2414 | FDA UDI | Class I | Active |
| Double Pump Kit, Gen 3 (2S), White, 27mm | PDW50 | FDA UDI | Class II | Active |
| Willow Sync, Pump Kit | PEG25 | FDA UDI | Class II | Active |
| Replacement Gen 3 21mm Flange | FR42159 | FDA UDI | Class II | Active |
| Replacement Container Insert, 27 mm | IR2746 | FDA UDI | Class II | Active |
| 17mm Sizing Inserts | SZ1763 | FDA UDI | Class I | Active |
| Elvie Nipple Cushion | ACCS-NCS02 | FDA UDI | Class I | Active |
| Elvie Stride 2 Silicone Insert - 19mm | EB01-INS-19 | FDA UDI | Class II | Active |
| Willow Go Container Bowl Accessory 5oz - Replacement | LBR572 | FDA UDI | Class II | Active |
| Elvie Stride 2 Cups | EB01-CUP22 | FDA UDI | Class II | Active |
| 2-Pack 27mm Flange 2.0 | F42734 | FDA UDI | Class II | Unknown |
| Willow Replacement Flange, 27mm | FR427 | FDA UDI | Class II | Unknown |
| Silicone Wearable Breast Pump | PP05 | FDA UDI | Class I | Active |
| Wave, Flapper Valves, 4 pack, Retail | RFL413 | FDA UDI | Class I | Active |
| Replacement Gen 3 Flextube | FTR55 | FDA UDI | Class II | Active |
| Elvie Pump Kit | EP01-02-COS | FDA UDI | Class II | Active |
| Elvie Pump Double | EP01-02-M-AMZ | FDA UDI | Class II | Active |
| Willow Pump Kit 2.0, White | PDW29 | FDA UDI | Class II | Unknown |
| Willow Go Container Bowl Accessory 7oz - Replacement | LBR773 | FDA UDI | Class II | Active |
| Willow Go Splash Guard | CCGSGR | FDA UDI | Class II | Active |
| Elvie Nipple Cushions | ACCS-NCL02 | FDA UDI | Class I | Active |
| Elvie Stride 2 Connect Kit (Double) | EB01-CON22 | FDA UDI | Class II | Active |
| Replacement Gen 3 24mm Flange | FR42456 | FDA UDI | Class II | Active |
| Elvie Stride | EB01 | FDA UDI | Class II | Active |
| Wave, Gasket, 2 pack, Retail | RG2P12 | FDA UDI | Class I | Active |
| Willow Go Flange Accessory Kit, 27 mm | LF2769 | FDA UDI | Class II | Active |
| Willow Go, 2 Splashguard Containers, 5oz | L1GC05 | FDA UDI | Class II | Active |
| Container Inserts, 21 mm x 2 | I2140 | FDA UDI | Class II | Active |
| Willow Go, Replacement Container Bowl, 5oz | R1GBR5 | FDA UDI | Class II | Active |
| Willow Replacement Pump | PRW19 | FDA UDI | Class II | Unknown |
| Gen 3 Pump Kit Retail Package, White – 21mm | PDW53 | FDA UDI | Class II | Active |
| Willow Replacement Flextube | FTR | FDA UDI | Class II | Active |
| Replacement Gen 3 27mm Flange | FR42757 | FDA UDI | Class II | Active |
| Elvie Stride 2 Diaphragm | EB01-DIA22 | FDA UDI | Class II | Active |
| Willow Go Container Accessory Kit, 5 oz | LC0565 | FDA UDI | Class II | Active |
| Elvie Stride 2 | EB01-22 | FDA UDI | Class II | Active |
| Replacement Container | CR43 | FDA UDI | Class II | Active |
| Willow Go Container Lid Accessory - Replacement | LLR074 | FDA UDI | Class II | Active |
| Willow Go, Replacement Container Bowl, 7oz | R2GBR7 | FDA UDI | Class II | Active |
| Willow Replacement Flange, 24mm | FR424 | FDA UDI | Class II | Unknown |
| 2pk Retail Package, Gen 3 21mm Flange | F42152 | FDA UDI | Class II | Active |
| 2-Pack 24mm Flange 2.0 | F42433 | FDA UDI | Class II | Unknown |
| Willow Charger | CW10 | FDA UDI | Class II | Active |
| Elvie Stride 2 Silicone Insert - 15mm | EB01-INS-15 | FDA UDI | Class II | Active |
| Elvie Stride 2 Breast Shield | EB01-BS22 | FDA UDI | Class II | Active |
| Elvie Stride 2 with Neck Strap | EB01-22-AMZ | FDA UDI | Class II | Active |
| 19mm Sizing Inserts | SZ1964 | FDA UDI | Class I | Active |
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