Momcozy Wearable Breast Pump - Momcozy Wearable Breast Pump (BP137)

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

No FDA recalls found in the data synced 22 Oct 2026.

Trade Name

Momcozy Wearable Breast Pump EUDAMED

momcozy GUDID

Generic Name

Breast pump, electric

Model / Reference

M5 EUDAMED

M5-Grey GUDID

Primary DI / UDI-DI

06975740360421

Basic UDI-DI

697574036BP3R

510(k) Number

K233880 ↗ 510(k)

K223693 ↗ GUDID

FDA Product Code

HGX

EMDN Code

Z12080303 Breast pumps

GMDN Term

Breast pump, electric

Models / Variants

Momcozy Wearable Breast Pump (BP137)

Momcozy Wearable Breast Pump (BP141)

Device Class

Class IIa EUDAMED

Class II 510(k)GUDID

Regulation

21 CFR Part 884.5160

EU market of registration

Malta

Advisory Committee

Obstetrics/Gynecology

FDA Decision

SESE Substantially Equivalent

GUDID distribution status

In Commercial Distribution

• Silver Nipple Protective Cups

  Class I

  CE/MDR

• Momcozy BP380- Red

  Class II

  GUDID on market

• Momcozy BP380- Grey D

  Class II

  GUDID on market

• Momcozy BP380- Grey

  Class II

  GUDID on market

• Momcozy S12 Pro, Pink, Single

  Class II

  GUDID on market

• Momcozy BP380- Red D

  Class II

  GUDID on market

See all devices from Shenzhen Root Innovation Technology Co., Ltd. →

• What are the key differences between the BP137 and BP141 models of the Momcozy Wearable Breast Pump?

  The Momcozy Wearable Breast Pump comes in two models, BP137 and BP141, but the provided data does not specify functional or design differences between them. Both models are classified as powered, wearable breast pumps intended for hands-free milk expression. The distinction may lie in features like battery life, suction intensity, or additional accessories, but these details are not explicitly mentioned in the data. For precise differences, refer to the manufacturer’s specifications or user manual.

• Can the Momcozy Wearable Breast Pump be used in an MRI environment?

  No, the Momcozy Wearable Breast Pump is explicitly designed for use in non-MRI environments. This is a critical safety note, as MRI machines generate strong magnetic fields that could interfere with or damage electronic medical devices. Always verify the environment before use to ensure compatibility.

• Are the Momcozy Wearable Breast Pump components reusable or single-use?

  The Momcozy Wearable Breast Pump is designed for both single-use and reusable applications, depending on the model. The data does not specify which model is which, so users should consult the manufacturer’s instructions or packaging to determine the intended use for their specific device. Proper cleaning and maintenance are required for reusable components to ensure hygiene and functionality.

• What regulatory approvals does the Momcozy Wearable Breast Pump hold, and how does this affect its use?

  The Momcozy Wearable Breast Pump is authorized under FDA 510(k) clearance and the EU Medical Device Regulation (MDR). This means it meets U.S. and EU standards for safety and effectiveness as a Class II medical device under the category *Pump, Breast, Powered*. While these approvals indicate regulatory compliance, they do not imply clinical suitability for every individual—users should follow manufacturer guidelines and consult healthcare providers for personalized advice.

• How should I store the Momcozy Wearable Breast Pump to maintain its performance and sterility?

  Storage instructions for the Momcozy Wearable Breast Pump are provided by the manufacturer, as noted in the data. While the device is available in sterile or non-sterile variants (depending on model), proper storage typically involves keeping it in a clean, dry environment away from direct sunlight or extreme temperatures. For reusable components, follow the manufacturer’s cleaning and storage protocols to prevent contamination and ensure longevity.