Areus(TM) Endoscopic Ultrasound Aspiration Needle (FNA)

FDA UDIEUDAMED

Class II (US FDA UDI)

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

Identity

Trade Name: Areus(TM) Endoscopic Ultrasound Aspiration Needle (FNA) FDA UDI
Generic Name: Ultrasound aspiration biopsy procedure kit FDA UDI
Device Name: Sheath: 1.8mm, Needle: 0.5mm, Needle Length out of sheath: 80mm, Material: Co-Cr Alloy, Working channel is more than or equal to 2.8mm, Working Length: 1375~1415mm, EUS FNA needle FDA UDI
Model / Reference: EUS-25-0-N FDA UDI
Description: Sheath: 1.8mm, Needle: 0.5mm, Needle Length out of sheath: 80mm, Material: Co-Cr Alloy, Working channel is more than or equal to 2.8mm, Working Length: 1375~1415mm, EUS FNA needle FDA UDI

Identifiers

Primary DI / UDI-DI: 06932503534628 FDA UDI
510(k) Number: K172309 FDA UDI
FDA Product Code: ODG FDA UDI
GMDN Term: Ultrasound aspiration biopsy procedure kit FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.1500 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 — 25 Gauge FDA UDI

Category: Ultrasound aspiration biopsy procedure kit

Areus(TM) Endoscopic Ultrasound Aspiration Needle (FNA) by Micro-Tech (Nanjing) Co., Ltd. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED

Similar devices

Also classified as Ultrasound aspiration biopsy procedure kit.

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EchoTip ProCore — Cook Ireland, Ltd. · Class II
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EchoTip — Cook Ireland, Ltd. · Class II

Cleared under the same submission

K172309 also covers:

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDD

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDD	—	Class II	Unknown
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 (2)

FDA UDI 7c1818a6-0015-4bb5-9e65-98f9cdf3baaf 36 fields · synced Jun 19, 2026
EUDAMED 1 fields · synced May 28, 2026