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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 1 of 3| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Elvie Stride 2 Silicone Insert - 17mm | EB01-INS-17 | FDA UDI | Class II | Active |
| 384 ct Milk Bags (8 Softpacks) | B38459 | FDA UDI | Class II | Active |
| Willow Replacement Pump 2.0, White | PRW31 | FDA UDI | Class II | Unknown |
| Willow Breast Pump | PDW00 | FDA UDI | Class II | Unknown |
| Willow Replacement Charger | CRW | FDA UDI | Class II | Active |
| Wave, Container 5oz, Replacement | RC0511 | FDA UDI | Class I | Active |
| Go, Single Pump Kit | L01 | FDA UDI | Class II | Active |
| Wave, Single, Tubing Set, Retail | RSTS15 | FDA UDI | Class I | Active |
| 96ct Milk Bag Package | B9651 | FDA UDI | Class II | Active |
| Container Inserts, 27 mm x 2 | I2742 | FDA UDI | Class II | Active |
| Elvie Stride Plus | EB01-02-Plus | FDA UDI | Class II | Active |
| Willow Go Replacement Pump | PDL61 | FDA UDI | Class II | Active |
| Elvie Pump Single AMZA | EP01-01-N4 | FDA UDI | Class II | Active |
| Willow Pump Kit 2.0, Gray | PDG30 | FDA UDI | Class II | Unknown |
| 15mm Sizing Inserts | SZ1562 | FDA UDI | Class I | Active |
| Replacement Container Caps, 2 pk | CCR47 | FDA UDI | Class II | Active |
| Silver Cup | 100-00032 | FDA UDI | Class I | Active |
| Elvie Stride 2 Silicone Insert - 21mm | EB01-INS-21 | FDA UDI | Class II | Active |
| Elvie Curve | EC01-1 | FDA UDI | Class I | Active |
| Container Accessory Kit, 24 mm x 2 | C2438 | FDA UDI | Class II | Active |
| Pump Kit, Gen 3 (2S), 2PK, White, 24mm | PDW48 | FDA UDI | Class II | Active |
| Wave, Handle, Replacement | RHR116 | FDA UDI | Class I | Active |
| Willow Breast Pump, Gray | PDG01 | FDA UDI | Class II | Unknown |
| Willow Go Lucy Container Accessory Kit, 7 oz | LC0766 | FDA UDI | Class II | Active |
| Willow Go, 2 Splashguard Containers, 7oz | L2GC07 | FDA UDI | Class II | Active |
| Container Accessory Kit, 21 mm x 2 | C2137 | FDA UDI | Class II | Active |
| Wave Single Manual Pump Kit | PMK10 | FDA UDI | Class I | Active |
| Container Inserts, 24 mm x 2 | I2441 | FDA UDI | Class II | Active |
| Replacement Container Insert, 24 mm | IR2445 | FDA UDI | Class II | Active |
| Elvie Stride 2 Valves | EB01-VLV23 | FDA UDI | Class II | Active |
| Willow Replacement Pump, Gray | PRG13 | FDA UDI | Class II | Unknown |
| Replacement 24mm Flange 2.0 | FR42435 | FDA UDI | Class II | Unknown |
| Replacement 27mm Flange 2.0 | FR42736 | FDA UDI | Class II | Unknown |
| SBD Retail Milk Bags, 48 ct | B4850 | FDA UDI | Class II | Active |
| Willow Go Container Accessory Duckbill Valves (2 pk) | LCD271 | FDA UDI | Class II | Active |
| Double Pump Kit, Willow Go | PDL60 | FDA UDI | Class II | Active |
| Willow Go USB Charging Cables Accessory (2 pk) | LCC275 | FDA UDI | Class II | Active |
| Willow Go Flange Accessory Kit, 21 mm | LF2167 | FDA UDI | Class II | Active |
| Elvie Stride 2 | EB01-21 | FDA UDI | Class II | Active |
| Willow Go Dual Charger Brick Accessory | WDCB76 | FDA UDI | Class II | Active |
| Gel Pack | GP2312 | FDA UDI | Class I | Active |
| 360, Double Pump Kit | PDW49 | FDA UDI | Class II | Active |
| 2-Pack Flextube | FT09 | FDA UDI | Class II | Unknown |
| Willow Go Flange Accessory Kit, 24 mm | LF2468 | FDA UDI | Class II | Active |
| 2-Pack Flange | F42407 | FDA UDI | Class II | Unknown |
| Elvie Stride 2 Connect Kit (Single) | EB01-CON21 | FDA UDI | Class II | Active |
| 2-Pack 27mm Flange | F42708 | FDA UDI | Class II | Active |
| Willow Replacement Pump 2.0, Gray | PRG32 | FDA UDI | Class II | Unknown |
| Replacement Container Insert, 21 mm | IR2144 | FDA UDI | Class II | Active |
| Elvie Stride 2 Silicone Insert - 24mm | EB01-INS-24 | FDA UDI | Class II | Active |
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