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Endoscopic Ultrasound Aspiration Needle

EUDAMEDFDA UDIFDA 510(k)

Class IIa (EU MDR)

Ref EUS-19-1-NRef EUS-22-0Ref EUS-22-0-NRef EUS-22-1-NRef EUS-19-0-NRef EUS-25-1Ref EUS-19-0Ref EUS-25-0

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

Identity

Trade Name
Areus(TM) Endoscopic Ultrasound Aspiration Needle (FNA) FDA UDI
Trident(TM) Endoscopic Ultrasound Biopsy Needle (FNB) FDA UDI
Generic Name
Ultrasound aspiration biopsy procedure kit FDA UDI
Device Name
Endoscopic Ultrasound Aspiration Needle EUDAMED
Sheath: 1.8mm, Needle: 0.7mm, Needle Length out of sheath: 80mm, Material: 304SS, Working channel is more than or equal to 2.8mm, Working Length: 1375~1415mm, EUS FNA needle FDA UDI
Sheath: 1.8mm, Needle: 0.7mm, 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
Sheath: 1.8mm, Needle: 1.1mm, 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
Sheath: 1.8mm, Needle: 1.1mm, Needle Length out of sheath: 80mm, Material: 304SS, Working channel is more than or equal to 2.8mm, Working Length: 1375~1415mm, EUS FNA needle FDA UDI
Sheath: 1.8mm, Needle: 0.5mm, Needle Length out of sheath: 80mm, Material: 304SS, Working channel is more than or equal to 2.8mm, Working Length: 1375~1415mm, EUS FNA needle FDA UDI
Sheath: 1.8mm, Needle; 1.1mm, 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 FNB needle FDA UDI
Sheath: 1.8mm, Needle: 0.7mm, 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 FNB needle FDA UDI
Model / Reference
EUS-19-1-N EUDAMEDFDA UDI
EUS-22-0 EUDAMEDFDA UDI
EUS-22-0-N EUDAMEDFDA UDI
EUS-22-1-N EUDAMEDFDA UDI
EUS-19-0-N EUDAMEDFDA UDI
EUS-25-1 EUDAMED
EUS-19-0 EUDAMEDFDA UDI
EUS-25-0 EUDAMEDFDA UDI
Description
Sheath: 1.8mm, Needle: 0.7mm, Needle Length out of sheath: 80mm, Material: 304SS, Working channel is more than or equal to 2.8mm, Working Length: 1375~1415mm, EUS FNA needle FDA UDI
Sheath: 1.8mm, Needle: 0.7mm, 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
Sheath: 1.8mm, Needle: 1.1mm, 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
Sheath: 1.8mm, Needle: 1.1mm, Needle Length out of sheath: 80mm, Material: 304SS, Working channel is more than or equal to 2.8mm, Working Length: 1375~1415mm, EUS FNA needle FDA UDI
Sheath: 1.8mm, Needle: 0.5mm, Needle Length out of sheath: 80mm, Material: 304SS, Working channel is more than or equal to 2.8mm, Working Length: 1375~1415mm, EUS FNA needle FDA UDI
Sheath: 1.8mm, Needle; 1.1mm, 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 FNB needle FDA UDI
Sheath: 1.8mm, Needle: 0.7mm, 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 FNB needle FDA UDI

Identifiers

Primary DI / UDI-DI
06902284550070 EUDAMED
06902284550049 EUDAMED
06902284550100 EUDAMED
06902284550094 EUDAMED
06902284550087 EUDAMED
06902284550056 EUDAMED
06902284550025 EUDAMED
06902284550063 EUDAMED
06932503534543 FDA UDI
06932503534604 FDA UDI
06932503534581 FDA UDI
06932503534529 FDA UDI
06932503534567 FDA UDI
06932503534574 FDA UDI
06932503534598 FDA UDI
Basic UDI-DI
B-06902284550070 EUDAMED
B-06902284550049 EUDAMED
B-06902284550100 EUDAMED
B-06902284550094 EUDAMED
B-06902284550087 EUDAMED
B-06902284550056 EUDAMED
B-06902284550025 EUDAMED
B-06902284550063 EUDAMED
510(k) Number
K172309 FDA UDI
FDA Product Code
ODG FDA UDI
FCG FDA UDI
EMDN Code
A01020199 NEEDLES AND KITS FOR HISTOLOGICAL AND CYTOLOGICAL BIOPSY OF SOFT TISSUES - OTHER EUDAMED
GMDN Term
Ultrasound aspiration biopsy procedure kit FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class II FDA UDI
Regulation Number
876.1500 FDA UDI
876.1075 FDA UDI
Market of Registration
Germany EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Needle Gauge — 22 Gauge FDA UDI
Needle Gauge — 19 Gauge FDA UDI
Needle Gauge — 25 Gauge FDA UDI

Endoscopic Ultrasound Aspiration Needle by Micro-Tech (Nanjing) Co., Ltd. — Class IIa — FDA_510K, MDD — listed in EUDAMED, FDA GUDID, FDA 510(k)

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

European Union Active

CE/MDD

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Manufacturer

Manufacturer
Micro-Tech (Nanjing) Co., Ltd.
EUDAMED SRN
CN-MF-000006950
Authorised Representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Sources (16)

  • EUDAMED a8116c67-1655-49c2-ac32-1461f85b48a6 61 fields · synced Jul 29, 2026
  • EUDAMED 030152ff-8947-4f36-a759-f80661e9210d 61 fields · synced May 16, 2026
  • EUDAMED b343705a-96b7-4bfc-962d-59fe2d358235 61 fields · synced May 17, 2026
  • EUDAMED eae9ae17-6662-4f5b-a6d5-97ba614ed7bb 61 fields · synced May 17, 2026
  • EUDAMED fdc31265-930e-4ab9-bc44-9b863e1a9a0d 61 fields · synced May 17, 2026
  • EUDAMED 88afa640-7ac5-473c-916d-146e782a33b8 61 fields · synced May 18, 2026
  • EUDAMED 87efeb03-7834-4cc3-80c0-3fcc1d786e73 61 fields · synced May 18, 2026
  • EUDAMED 12dcef81-a1b2-4c54-a9a6-0afee657f4a6 61 fields · synced May 18, 2026
  • FDA UDI 6a4e4282-6658-4520-b764-88564e17f71d 36 fields · synced May 25, 2026
  • FDA UDI 909cf524-e4f6-4e02-ae5a-d3d5d1efc3a4 36 fields · synced May 30, 2026
  • FDA UDI d59b6a15-b866-4a5d-a40e-6d4b09c4d8ee 36 fields · synced May 30, 2026
  • FDA UDI 008b7494-9480-4c07-9ceb-33e420266586 36 fields · synced May 30, 2026
  • FDA UDI e342384f-f603-4e50-a707-b3a9afc9c65b 36 fields · synced May 30, 2026
  • FDA UDI 8c745625-4dcc-4fd4-a981-849ff678f677 36 fields · synced May 30, 2026
  • FDA UDI 4955a0b9-da0d-4655-99ac-d67b51561d29 36 fields · synced May 30, 2026
  • FDA 510(k) K172309 1 fields · synced May 18, 2026