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Injection Needle
FDA UDIEUDAMEDFDA 510(k)Class II (US FDA UDI)
Ref JIN12-254232002Ref JIN02-195232302Ref IN12-236181802
Identity
- Trade Name
- Injection Needle FDA UDI
- Generic Name
- Submucosal injection needle FDA UDI
- Device Name
- Injection Needle EUDAMEDPOM inner tuber,Needle Length 6mm,with metal cap 19G*6*2.3*200,Shroat stucture FDA UDI
- Model / Reference
- JIN12-254232002 EUDAMEDJIN02-195232302 EUDAMEDIN12-236181802 EUDAMEDIN12-196232002 FDA UDI
- Description
- POM inner tuber,Needle Length 6mm,with metal cap 19G*6*2.3*200,Shroat stucture FDA UDI
Identifiers
- Catalog Number
- IN12-196232002 FDA UDI
- Primary DI / UDI-DI
- 06902284577411 EUDAMED06902284577305 EUDAMED06902284579972 EUDAMED06932503533089 FDA UDI
- Basic UDI-DI
- 6902284SI45019K3 EUDAMED
- 510(k) Number
- K150434 FDA UDI
- FDA Product Code
- FBK FDA UDI
- EMDN Code
- G03020101 DIGESTIVE ENDOSCOPY, SINGLE-LUMEN NEEDLES EUDAMED
- GMDN Term
- Submucosal injection needle FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1500 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
- Length — 200 Centimeter FDA UDINeedle Gauge — 19 Gauge FDA UDI
Category: Submucosal injection needle
Injection Needle by Micro-Tech (Nanjing) Co., Ltd. — Class II — MDR, FDA_510K — listed in FDA GUDID, EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Similar devices
Also classified as Submucosal injection needle.
- Disposable Injection Needles — Ningbo Xinwell Medical Technology Co., Ltd. · Class II
- Disposable Injection Needles — Ningbo Xinwell Medical Technology Co., Ltd. · Class II
- Disposable Injection Needles — Ningbo Xinwell Medical Technology Co., Ltd. · Class II
- Disposable Injection Needles — Ningbo Xinwell Medical Technology Co., Ltd. · Class II
- Disposable Injection Needles — Ningbo Xinwell Medical Technology Co., Ltd. · Class II
- Disposable Injection Needles — Ningbo Xinwell Medical Technology Co., Ltd. · Class II
- Disposable Injection Needles — Ningbo Xinwell Medical Technology Co., Ltd. · Class II
- Disposable Injection Needles — Ningbo Xinwell Medical Technology Co., Ltd. · Class II
Cleared under the same submission
K150434 also covers:
- Injection Needle — Micro-Tech (Nanjing) Co., Ltd.
- Injection Needle — Micro-Tech (Nanjing) Co., Ltd.
- Injection Needle — Micro-Tech (Nanjing) Co., Ltd.
- Injection Needle — Micro-Tech (Nanjing) Co., Ltd.
- Injection Needle — Micro-Tech (Nanjing) Co., Ltd.
- Injection Needle — Micro-Tech (Nanjing) Co., Ltd.
- Injection Needle — Micro-Tech (Nanjing) Co., Ltd.
- Injection Needle — Micro-Tech (Nanjing) Co., Ltd.
- Injection Needle — Micro-Tech (Nanjing) Co., Ltd.
- Injection Needle — Micro-Tech (Nanjing) Co., Ltd.
- Injection Needle — Micro-Tech (Nanjing) Co., Ltd.
- Injection Needle — Micro-Tech (Nanjing) Co., Ltd.
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA 510(k) | United States | FDA_510K | K260262 | Class II | Active |
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Manufacturer
- Manufacturer
- Micro-Tech (Nanjing) Co., Ltd.
Sources (5)
- FDA UDI 6f084f26-4ca2-4488-9391-bfd05ed69c28 37 fields · synced Sep 30, 2026
- EUDAMED 47fd3e8e-3978-4349-885b-82dc756b45b3 61 fields · synced Sep 17, 2026
- EUDAMED 16be8002-fa46-4325-8be5-9384a8bde2db 61 fields · synced Sep 17, 2026
- EUDAMED 0568aa0b-c4fa-48ea-9eed-54e9aa79cd3b 61 fields · synced Sep 17, 2026
- FDA 510(k) K260262 1 fields · synced Jun 18, 2026