Identity
- Trade Name
- EXEL 10-12mL SYR 20GX1" EUDAMEDEXEL Disposable Syringe with Needle, 10mL Luer Lock Tip W/ 20G x 1” EUDAMEDEXEL Syringes FDA UDI
- Generic Name
- General-purpose syringe, single-use FDA UDI
- Device Name
- Syringe with needle EUDAMEDEXEL Disposable Syringe with Needle EUDAMEDSyringe, 10CC, Luer Lock, 20G X 1 FDA UDI
- Model / Reference
- 26254 EUDAMEDFDA UDI
- Description
- Syringe, 10CC, Luer Lock, 20G X 1 FDA UDI
Identifiers
- Catalog Number
- 26254 FDA UDI
- Primary DI / UDI-DI
- 00020221262544 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00020221262544 EUDAMED20221SYRNDL261PG EUDAMED
- FDA Product Code
- FMF FDA UDI
- EMDN Code
- A0101010102 HYPODERMIC SYRINGE NEEDLES, W/O SAFETY SYSTEMS EUDAMEDA020102020101 INFUSION AND IRRIGATION SYRINGES, LUER LOCK CONE, 3-PIECE WITH NEEDLE, 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
EXEL 10-12mL SYR 20GX1" 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-00020221262544 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-00020221262544 | 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 0f2ca92a-9c7c-4f28-8a6f-81e2df04f40e 61 fields · synced Jul 29, 2026
- FDA UDI d520a729-dccd-4135-88a8-2053b5e661ec 34 fields · synced May 30, 2026
- EUDAMED 881d9717-86f7-4d3a-ab42-9688d0da1884 61 fields · synced Jul 29, 2026