Single-use Bronchoscope

FDA UDI

Class II (US FDA UDI)

by Shenzhen HugeMed Medical Technical Development Co., Ltd.

Identity

Trade Name: Single-use Bronchoscope FDA UDI
Generic Name: Flexible video bronchoscope, single-use FDA UDI
Model / Reference: BR-M42 FDA UDI

Identifiers

Primary DI / UDI-DI: 06970462546726 FDA UDI
510(k) Number: K222910 FDA UDI
FDA Product Code: EOQ FDA UDI
GMDN Term: Flexible video bronchoscope, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 874.4680 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

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

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Flexible video bronchoscope, single-use

Single-use Bronchoscope by Shenzhen HugeMed Medical Technical Development Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Flexible video bronchoscope, single-use.

aScope™ 5 Broncho HD 5.0/2.2 Sampler Set — Ambu A/S · Class II
aScope™ 4 Broncho Slim 3.8/1.2 — Ambu A/S · Class II
Single-Use flexible Video Bronchoscope — HUNAN VATHIN MEDICAL INSTRUMENT CO., LTD. · Class II
aScope™ 4 Broncho Large 5.8/2.8 — Ambu A/S · Class II
Single-Use flexible Video Bronchoscope — Hunan Vathin Medical Instrument Co., Ltd · Class II
aScope™ 5 Broncho 4.2/2.2 Sampler Set — Ambu A/S · Class II
Single-Use flexible Video Bronchoscope — Hunan Vathin Medical Instrument Co., Ltd · Class II
GlideScope® — Verathon Medical (Canada) ULC · Class II

Cleared under the same submission

K222910 also covers:

Single-use Bronchoscope — Shenzhen HugeMed Medical Technical Development Co., Ltd.

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Shenzhen HugeMed Medical Technical Development Co., Ltd.

Sources (1)

FDA UDI 15c4bb49-9799-466b-97a0-4360a118d370 33 fields · synced Jun 8, 2026