Areus(TM) Endobronchial Ultrasound Aspiration Needle

FDA UDI

Class II (US FDA UDI)

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

Identity

Trade Name: Areus(TM) Endobronchial Ultrasound Aspiration Needle FDA UDI
Generic Name: Body aspiration needle, single-use FDA UDI
Device Name: Maximum insertion portion diameter:1.8mm,Needle:19G,Maximum needle length:40mm,Material: Nitinol, Working channel: is more than or equal to 2.0mm,Working Length:720~760mm,FNA needle FDA UDI
Model / Reference: EBUS00001 FDA UDI
Description: Maximum insertion portion diameter:1.8mm,Needle:19G,Maximum needle length:40mm,Material: Nitinol, Working channel: is more than or equal to 2.0mm,Working Length:720~760mm,FNA needle FDA UDI

Identifiers

Primary DI / UDI-DI: 06932503549219 FDA UDI
510(k) Number: K213060 FDA UDI
FDA Product Code: KTI FDA UDI
GMDN Term: Body aspiration needle, 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: Needle Gauge — 19 Gauge FDA UDI

Category: Body aspiration needle, single-use

Areus(TM) Endobronchial Ultrasound Aspiration Needle by Micro-Tech (Nanjing) Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Body aspiration needle, single-use.

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COMPLETE-CHIBA MR — STERYLAB SRL · Class II
Invivo — Philips DS North America LLC · Class II
BIOMOL — H.S. HOSPITAL SERVICE SPA · Class II
MReye — COOK INCORPORATED · Class II

Cleared under the same submission

K213060 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 8dca26be-510b-4d83-8d14-da956d5f2533 36 fields · synced Jun 8, 2026