Single-Use Video Bronchoscope

FDA UDI

Class II (US FDA UDI)

by Micro-Tech (Nanjing) Co., Ltd.

Identity

Trade Name: Single-Use Video Bronchoscope FDA UDI
Generic Name: Flexible video bronchoscope, single-use FDA UDI
Device Name: Single-Use Video Bronchoscope:Maximum insertion portion width is 6.3mm. FDA UDI
Model / Reference: SVB33001 FDA UDI
Description: Single-Use Video Bronchoscope:Maximum insertion portion width is 6.3mm. FDA UDI

Identifiers

Primary DI / UDI-DI: 06932503571135 FDA UDI
510(k) Number: K213782 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

Yes

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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Outer Diameter — 6.3 Millimeter FDA UDI
Pore Size — 2.8 Millimeter FDA UDI
Catheter Working Length — 600 Millimeter FDA UDI

Category: Flexible video bronchoscope, single-use

Single-Use Video Bronchoscope by Micro-Tech (Nanjing) 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

K213782 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: Micro-Tech (Nanjing) Co., Ltd.

Sources (1)

FDA UDI b547bf93-0627-4c4f-894b-e15798323f67 36 fields · synced May 30, 2026