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EXEL 2-3mL SYR W/ SAFETY NDL 18GX1-1/2"
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 27110
Identity
- Trade Name
- EXEL 2-3mL SYR W/ SAFETY NDL 18GX1-1/2" EUDAMEDEXEL Disposable Syringe with SecureTouch Safety Needle, 3mL Luer Lock Tip W/ 18G X 1-1/2” EUDAMEDEXEL Syringes FDA UDI
- Generic Name
- General-purpose syringe, single-use FDA UDI
- Device Name
- Syringe with safety needle EUDAMEDEXEL Disposable Syringe with SecureTouch Safety Needle EUDAMEDEXEL 2-3CC SYR W/ SAFETY NDL 18GX1-1/2" L-L FDA UDI
- Model / Reference
- 27110 EUDAMEDFDA UDI
- Description
- EXEL 2-3CC SYR W/ SAFETY NDL 18GX1-1/2" L-L FDA UDI
Identifiers
- Catalog Number
- 27110 FDA UDI
- Primary DI / UDI-DI
- 00020221271102 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00020221271102 EUDAMED20221SYRSFT261TX EUDAMED
- 510(k) Number
- K861153 FDA UDI
- FDA Product Code
- FMF FDA UDI
- EMDN Code
- A0101010101 HYPODERMIC SYRINGE NEEDLES, WITH SAFETY SYSTEMS EUDAMEDA02010205 INFUSION AND IRRIGATION SYRINGES WITH SAFETY SYSTEM, SINGLE-USE EUDAMED
- GMDN Term
- General-purpose syringe, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 880.5860 FDA UDI
- Market of Registration
- Netherlands EUDAMEDAustria 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
Yes
EUDAMED
Measuring Function
No
EUDAMEDEUDAMED
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
Category: Hypodermic needle, single-use
EXEL 2-3mL SYR W/ SAFETY NDL 18GX1-1/2" by Exelint International, Co. — Class IIa — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID
Similar devices
Also classified as Hypodermic needle, single-use.
- Monoject — Cardinalhealth · Class II
- Pinpoint GT — Bard Access Systems, Inc. · Class II
- Safety Needle — Jiangsu Micsafe Medical Technology Co., Ltd · Class IIa
- Syringe w/Needle, Non-Toxic, 25G x 1", Luer Lock — Dynarex Corp. · Class II
- Yeso med — WUXI YUSHOU MEDICAL APPLIANCES CO., LTD. · Class II
- EasyTouch — MHC Medical Products · Class II
- STERiJECT TM — TSK LABORATORY, JAPAN · Class II
- Comfort EZ Pro — S.D.I. USA, INC. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-00020221271102 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-00020221271102 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Exelint International, Co.
- EUDAMED SRN
- US-MF-000037396
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (3)
- EUDAMED ea8fd845-46c5-46fb-9328-3739588e93ed 61 fields · synced Jun 20, 2026
- FDA UDI e490ca16-b840-41e9-8ce0-b156ad92251b 36 fields · synced May 30, 2026
- EUDAMED b5695348-99a5-4dfb-8b52-72327479902b 61 fields · synced Jun 20, 2026