Identity
- Trade Name
- EXEL 1mL SYR W/ SAFETY NDL 25GX1" EUDAMEDEXEL Disposable Syringe with SecureTouch Safety Needle, 1mL Luer Lock Tip W/ 25G X 1” EUDAMEDEXEL 1mL SYR W/ SAFETY NDL 25GX1" L-L FDA UDI
- Generic Name
- General-purpose syringe/needle FDA UDI
- Device Name
- Syringe with safety needle EUDAMEDEXEL Disposable Syringe with SecureTouch Safety Needle EUDAMEDEXEL 1mL SYR W/ SAFETY NDL 25GX1" L-L, 100/BX, 20BX/CS, 2000PC/CS FDA UDI
- Model / Reference
- 27045 EUDAMEDFDA UDI
- Description
- EXEL 1mL SYR W/ SAFETY NDL 25GX1" L-L, 100/BX, 20BX/CS, 2000PC/CS FDA UDI
Identifiers
- Catalog Number
- 27045 FDA UDI
- Primary DI / UDI-DI
- 00020221270457 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00020221270457 EUDAMED20221SYRSFT261TX EUDAMED
- FDA Product Code
- MEG 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 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 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" by Exelint International, Co. — Class IIa — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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-00020221270457 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-00020221270457 | 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 3d363878-c547-4e67-b29f-ff04428d9ed2 61 fields · synced Jun 18, 2026
- FDA UDI ba718fa8-dca4-43ae-ae2a-bba6ba25b97c 35 fields · synced May 30, 2026
- EUDAMED c84a36ea-fc23-44ef-8adc-7f376124d64e 61 fields · synced Jun 18, 2026