Horigen

FDA UDI

Class II (US FDA UDI)

by Guangdong Horigen Mother & Baby Products Co., Ltd.

Identity

Trade Name: HORIGEN FDA UDI
Generic Name: Breast pump, electric FDA UDI
Device Name: single electric breast pump FDA UDI
Model / Reference: XN-2207M1 FDA UDI
Description: single electric breast pump FDA UDI

Identifiers

Primary DI / UDI-DI: 06940657922031 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

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

MRI Safety

MR Safe FDA UDI

Category: Breast pump, electric

Horigen by Guangdong Horigen Mother & Baby Products Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Guangdong Horigen Mother & Baby Products Co., Ltd.

Sources (1)

FDA UDI 5c6ce5a5-10b6-4e5f-8c3b-ba9254d7339d 33 fields · synced Jun 7, 2026