Headgear

FDA UDI

Class I (US FDA UDI)

by Suzhou Yuyue Medical Technology Co., Ltd.

Identity

Trade Name: Headgear FDA UDI
Generic Name: Orthodontic chin cap/cup FDA UDI
Device Name: Headgear for YUWELL Sleep Apnea Breathing Therapy Mask (YF-02 & YN-03) FDA UDI
Model / Reference: H4 FDA UDI
Description: Headgear for YUWELL Sleep Apnea Breathing Therapy Mask (YF-02 & YN-03) FDA UDI

Identifiers

Primary DI / UDI-DI: 06922166511500 FDA UDI
FDA Product Code: BTK FDA UDI
GMDN Term: Orthodontic chin cap/cup FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 868.5560 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

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

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Orthodontic chin cap/cup

Headgear by Suzhou Yuyue Medical Technology Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Headgear — Suzhou Yuyue Medical Technology Co., Ltd. · Class I

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 I	Pending data

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Manufacturer

Manufacturer: Suzhou Yuyue Medical Technology Co., Ltd.

Sources (1)

FDA UDI 07cf764e-1ce8-4bc5-91ee-6bb26eb1b653 33 fields · synced May 31, 2026