← Back to catalogue
EXEL Disposable Syringe with Needle, 1mL Luer Slip Tip W/ 26G x 3/8"
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 26045
Identity
- Trade Name
- EXEL Disposable Syringe with Needle, 1mL Luer Slip Tip W/ 26G x 3/8" EUDAMEDEXEL 1ml SYRINGE 26Gx3/8" L-S FDA UDI
- Generic Name
- General-purpose syringe/needle FDA UDI
- Device Name
- EXEL Disposable Syringe with Needle EUDAMEDEXEL 1ml SYRINGE 26Gx3/8" L-S, 100/BX, 1000/CS FDA UDI
- Model / Reference
- 26045 EUDAMEDFDA UDI
- Description
- EXEL 1ml SYRINGE 26Gx3/8" L-S, 100/BX, 1000/CS FDA UDI
Identifiers
- Catalog Number
- 26045 FDA UDI
- Primary DI / UDI-DI
- 00020221260458 EUDAMEDFDA UDI
- Basic UDI-DI
- 20221SYRNDL261PG EUDAMED
- 510(k) Number
- K861153 FDA UDI
- FDA Product Code
- FMF FDA UDI
- EMDN Code
- A020102010201 INFUSION AND IRRIGATION SYRINGES, LUER CONE, 3-PIECE WITH NEEDLE, 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
- Austria 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
Yes
EUDAMED
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 Disposable Syringe with Needle, 1mL Luer Slip Tip W/ 26G x 3/8" by Exelint International, Co. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 20221SYRNDL261PG | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Exelint International, Co.
- EUDAMED SRN
- US-MF-000037396
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED a286fd59-57d0-4a21-bed7-b9414da0fe4f 61 fields · synced Oct 7, 2026
- FDA UDI fb87d696-3ae0-44dd-bf2c-873402489d80 36 fields · synced May 30, 2026