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Sign in to claim this brandCIMILRE CO ., LTD
US
Last updated May 24, 2026
What CIMILRE CO ., LTD makes
Cimilre Co., Ltd manufactures electric and manual breast pumps designed for lactation support. Their portfolio includes devices compatible with various breastfeeding needs, such as hospital-grade and portable models.
The company’s products are regulated under FDA Class I and Class II classifications, with some devices authorised via 510(k) and others through the De Novo pathway. These devices are listed in the FDA’s regulatory databases.
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 Cimilre Co., Ltd primarily manufacture?
Cimilre Co., Ltd specializes in breast pumps, including both electric and manual models. These devices are designed to support lactation and cater to different breastfeeding needs, such as hospital-grade or portable options. The focus is on products that assist mothers in expressing milk efficiently and comfortably.
Where is Cimilre Co., Ltd based, and what does that mean for its regulatory oversight?
Cimilre Co., Ltd is based in the United States, which means its devices fall under FDA jurisdiction. The FDA regulates these products to ensure safety, effectiveness, and compliance with medical device standards. Since the company operates in the US, its devices are subject to FDA classification and authorisation processes, such as 510(k) clearances or De Novo pathways.
Which regulatory registries or databases list Cimilre Co., Ltd’s devices?
Cimilre Co., Ltd’s devices are listed in the FDA’s regulatory databases, specifically under the 510(k) Premarket Notification and De Novo pathways. These registries track authorised medical devices in the US, ensuring transparency for healthcare providers, patients, and regulators. The inclusion in these databases confirms compliance with FDA requirements for classification and market authorisation.
How are Cimilre Co., Ltd’s breast pumps classified under FDA regulations?
Cimilre Co., Ltd’s breast pumps are classified as Class I or Class II devices under FDA regulations. Class I devices generally pose minimal risk and often require general controls for compliance, while Class II devices may need special controls to ensure safety and effectiveness. The classification determines the regulatory pathway—such as 510(k) submissions or De Novo requests—required to authorise these products for market.
Why do some of Cimilre Co., Ltd’s devices require a 510(k) clearance while others may use the De Novo pathway?
The FDA assigns device classifications based on risk levels and intended use. If a breast pump is similar to a predicate device (a legally marketed device with established safety and performance), it may require a 510(k) Premarket Notification to demonstrate substantial equivalence. However, if the device represents a new technology with no predicate or significant risk reduction, it may qualify for the De Novo pathway, where the FDA reviews it as a Class II device through a formal submission process. This ensures appropriate oversight tailored to the device’s innovation and risk profile.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- cimilrebreastpumps.com
- —
- —
- [email protected]
- Phone
- 888-394-2422
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 689851831
Catalogue (132)
Page 3 of 3| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Ameda® | 102X32 | FDA UDI | Class II | Active |
| Symmetrical Health, LLC | CIMILRE 21mm shield set 0f 2 | FDA UDI | Class II | Active |
| Stella Baby USA | SB350212-S | FDA UDI | Class II | Active |
| Motif Medical | AAA0022-03 | FDA UDI | Class II | Active |
| Symmetrical Health, LLC | CIMILRE Tubing -set of 2 | FDA UDI | Class II | Active |
| Ameda® | 102X15 | FDA UDI | Class II | Active |
| Motif Medical | AAA0013-10 | FDA UDI | Class II | Active |
| Motif Medical | AAA0022-07 | FDA UDI | Class II | Active |
| hygeia | 30-0130 | FDA UDI | Class II | Active |
| Stella Baby USA | SB830032-S | FDA UDI | Class II | Active |
| Symmetrical Health, LLC | CIMILRE Collection kit 28mm -set of 2 | FDA UDI | Class II | Active |
| Stella Baby USA | SB830032 | FDA UDI | Class II | Active |
| Motif Medical | Motif Medical LUNA | FDA UDI | Class II | Active |
| Stella Baby USA | SB550002-S | FDA UDI | Class II | Active |
| Symmetrical Health, LLC | CIMILRE Power Adapter (1) | FDA UDI | Class II | Active |
| Motif Medical | AAA0022-14 | FDA UDI | Class II | Active |
| Symmetrical Health, LLC | cimilre collection kit 21mm | FDA UDI | Class II | Active |
| Motif Medical | AAA0022-15 | FDA UDI | Class II | Active |
| Motif Medical | AAA0022-02 | FDA UDI | Class II | Active |
| hygeia | 30-0124 | FDA UDI | Class II | Active |
| Motif Medical | AAA0022-01 | FDA UDI | Class II | Active |
| Motif Medical | AAA0013-26 | FDA UDI | Class II | Active |
| Motif Medical | AAA0022-09 | FDA UDI | Class II | Active |
| Motif Medical | 301Z19 | FDA UDI | Class II | Active |
| Symmetrical Health, LLC | Wide silicone Nipple Set | FDA UDI | Class II | Active |
| Motif Medical | AAA0013-24 | FDA UDI | Class II | Active |
| hygeia | 40-0044 | FDA UDI | Class II | Active |
| Symmetrical Health, LLC | CM0A22 | FDA UDI | Class II | Active |
| Motif Medical | 301Z28 | FDA UDI | Class II | Active |
| Symmetrical Health, LLC | CIMILRE 24mm shield set of 2 | FDA UDI | Class II | Active |
| CIMILRE Free-T2 Plus | K221708 | FDA 510(k) | Class II | Active |
| CIMLRE F1 and CIMILRE S3 | K162870 | FDA 510(k) | Class II | Active |
Related Companies
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Cimilre Co., Ltd. Cheonan-si Chungnam · KR FEI 3013561139