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EXEL Disposable Syringe with Needle, 3mL Luer Lock Tip W/ 25G x 5/8"
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 26101
Identity
- Trade Name
- EXEL Disposable Syringe with Needle, 3mL Luer Lock Tip W/ 25G x 5/8" EUDAMEDEXEL Syringes FDA UDI
- Generic Name
- General-purpose syringe, single-use FDA UDI
- Device Name
- EXEL Disposable Syringe with Needle EUDAMEDSyringe, 3CC, Luer Lock, 23G x 1 FDA UDI
- Model / Reference
- 26101 EUDAMEDFDA UDI
- Description
- Syringe, 3CC, Luer Lock, 23G x 1 FDA UDI
Identifiers
- Catalog Number
- 26101 FDA UDI
- Primary DI / UDI-DI
- 00020221261011 EUDAMEDFDA UDI
- Basic UDI-DI
- 20221SYRNDL261PG EUDAMED
- FDA Product Code
- FMF FDA UDI
- EMDN Code
- A020102020101 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
- 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
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 Disposable Syringe with Needle, 3mL Luer Lock Tip W/ 25G x 5/8" 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 |
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Manufacturer
- Manufacturer
- Exelint International, Co.
- EUDAMED SRN
- US-MF-000037396
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 7536b3ae-f6e9-4470-8023-6d59687d6c56 61 fields · synced Oct 6, 2026
- FDA UDI 5552db0c-5e0f-499b-a789-ea6f12de0330 34 fields · synced May 30, 2026