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EXEL 1mL SYR W/ SAFETY NDL 25GX1-1/2"
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 27046Ref 27042Ref 27047Ref 27044
Identity
- Trade Name
- EXEL 1mL SYR W/ SAFETY NDL 25GX1-1/2" EUDAMEDEXEL Disposable Syringe with SecureTouch Safety Needle, 1mL Luer Lock Tip W/ 25G x 1" EUDAMEDA0101010101 EUDAMEDEXEL 1mL SYR W/ SAFETY NDL 25GX5/8" EUDAMEDEXEL Disposable Syringe with SecureTouch Safety Needle, 1mL Luer Lock Tip W/ 23G X 1” EUDAMEDEXEL Disposable Syringe with SecureTouch Safety Needle, 1mL Luer Lock Tip W/ 25G X 5/8” EUDAMEDEXEL Disposable Syringe with SecureTouch Safety Needle, 1mL Luer Lock Tip W/ 25G X 1-1/2” EUDAMEDEXEL 1mL SYR W/ SAFETY NDL 25GX1-1/2" L-L FDA UDIEXEL Syringes FDA UDIEXEL 1mL SYR W/ SAFETY NDL 23GX1" L-L FDA UDIEXEL 1mL SYR W/ SAFETY NDL 25GX1" L-L FDA UDI
- Generic Name
- General-purpose syringe/needle FDA UDIGeneral-purpose syringe, single-use FDA UDI
- Device Name
- Syringe with safety needle EUDAMEDEXEL Disposable Syringe with SecureTouch Safety Needle EUDAMEDEXEL 1mL SYR W/ SAFETY NDL 25GX1-1/2" L-L, 100/BX, 20BX/CS, 2000pcs/CS FDA UDIEXEL 1CC W/ SAFETY NDL 25G X 5/8 FDA UDIEXEL 1mL SYR W/ SAFETY NDL 23GX1" L-L, 50/BX, 6BX/CS, 300/CS FDA UDIEXEL 1mL SYR W/ SAFETY NDL 25GX1" L-L, 50/BX, 6BX/CS, 300/CS FDA UDI
- Model / Reference
- 27046 EUDAMEDFDA UDI27042 EUDAMEDFDA UDI27047 EUDAMEDFDA UDI27044 EUDAMEDFDA UDI
- Description
- EXEL 1mL SYR W/ SAFETY NDL 25GX1-1/2" L-L, 100/BX, 20BX/CS, 2000pcs/CS FDA UDIEXEL 1CC W/ SAFETY NDL 25G X 5/8 FDA UDIEXEL 1mL SYR W/ SAFETY NDL 23GX1" L-L, 50/BX, 6BX/CS, 300/CS FDA UDIEXEL 1mL SYR W/ SAFETY NDL 25GX1" L-L, 50/BX, 6BX/CS, 300/CS FDA UDI
Identifiers
- Catalog Number
- 27046 FDA UDI27044 FDA UDI27047 FDA UDI27042 FDA UDI
- Primary DI / UDI-DI
- 00020221270464 EUDAMEDFDA UDI00020221270426 EUDAMEDFDA UDI00020221270471 EUDAMEDFDA UDI00020221270440 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00020221270464 EUDAMED20221SYRSFT261TX EUDAMEDB-00020221270471 EUDAMEDB-00020221270440 EUDAMED
- 510(k) Number
- K861153 FDA UDI
- FDA Product Code
- MEG FDA UDIFMF 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/needle FDA UDIGeneral-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
No
FDA UDIFDA 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
EXEL 1mL SYR W/ SAFETY NDL 25GX1-1/2" by Exelint International, Co. — Class IIa — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID
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-00020221270464 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-00020221270464 | 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 (11)
- EUDAMED 383faa99-fdf2-4bee-94dd-778e8392dd98 61 fields · synced Oct 8, 2026
- EUDAMED a802d392-c3e0-4915-a471-17e0f1ca4385 61 fields · synced May 17, 2026
- EUDAMED 1708c143-f5df-4d0f-9cd7-15ca9b580c91 61 fields · synced May 18, 2026
- EUDAMED f6fc3cb3-95df-46e5-83fe-f15b1252b24b 61 fields · synced May 19, 2026
- FDA UDI bf525675-4a7f-4483-9344-7295f8ec11ec 35 fields · synced May 30, 2026
- FDA UDI 679ab8e3-69b7-4055-baa9-de51ae28c949 36 fields · synced May 30, 2026
- FDA UDI 351b1102-a252-4087-a32c-a7027248b489 35 fields · synced May 30, 2026
- FDA UDI 67ea4dcd-fa85-434d-8c17-b52b8367c927 35 fields · synced May 30, 2026
- EUDAMED e273a257-f6c8-403a-acff-071cd589ec3d 61 fields · synced Jun 20, 2026
- EUDAMED 28f7a3ed-d924-4aee-aa11-fa7fc0e5fe12 61 fields · synced Jul 24, 2026
- EUDAMED 9033a41a-f25f-4996-9c41-5c0f68047de0 61 fields · synced Jul 24, 2026