Spectra

FDA UDI

Class II (US FDA UDI)

by Uzinmedicare Co., Ltd.

Identity

Trade Name: Spectra FDA UDI
Generic Name: Breast pump, electric FDA UDI
Device Name: The Spectra Wearable is powered breast pumps intended for use of lactating women to stimulate, express and collect milk from user’s breast. The final product is packed in a box with neccessary connecting parts including breast shied, silicone valve, silicone membrane, bottle connector, handsfree bottle, airtight cap, power adaptor and instruction for use. so, the user can use the device right after receving them. FDA UDI
Model / Reference: Spectra Wearable FDA UDI
Description: The Spectra Wearable is powered breast pumps intended for use of lactating women to stimulate, express and collect milk from user’s breast. The final product is packed in a box with neccessary connecting parts including breast shied, silicone valve, silicone membrane, bottle connector, handsfree bottle, airtight cap, power adaptor and instruction for use. so, the user can use the device right after receving them. FDA UDI

Identifiers

Primary DI / UDI-DI: 08809108017697 FDA UDI
510(k) Number: K220926 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

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Breast pump, electric

Spectra by Uzinmedicare Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K220926 also covers:

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: Uzinmedicare Co., Ltd.

Sources (1)

FDA UDI 13e0c825-5004-4e05-b7c6-5d3cda092ae3 36 fields · synced May 30, 2026