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EXEL Disposable Syringe, 1mL Luer Slip Tip W/ LDS Gasket
EUDAMEDFDA UDIClass I (EU MDR)
Ref 26048
Identity
- Trade Name
- EXEL Disposable Syringe, 1mL Luer Slip Tip W/ LDS Gasket EUDAMEDEXEL Syringes FDA UDI
- Generic Name
- General-purpose syringe/needle FDA UDI
- Device Name
- EXEL Disposable Syringe EUDAMEDSyringe, 1CC, Luer Slip with Cap FDA UDI
- Model / Reference
- 26048 EUDAMEDFDA UDI
- Description
- Syringe, 1CC, Luer Slip with Cap FDA UDI
Identifiers
- Catalog Number
- 26048 FDA UDI
- Primary DI / UDI-DI
- 00020221260489 EUDAMEDFDA UDI
- Basic UDI-DI
- 20221SYRONLY263ES EUDAMED
- 510(k) Number
- K861153 FDA UDI
- FDA Product Code
- FMF FDA UDI
- EMDN Code
- A020102010202 INFUSION AND IRRIGATION SYRINGES, LUER CONE, 3-PIECE WITHOUT NEEDLE, SINGLE-USE EUDAMED
- GMDN Term
- General-purpose syringe/needle FDA UDI
Classification
- Device Class
- Class I 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, 1mL Luer Slip Tip W/ LDS Gasket by Exelint International, Co. — Class I — 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 | 20221SYRONLY263ES | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | 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 43461a07-3c6e-48b6-b477-486e16ea28b1 61 fields · synced Jun 19, 2026
- FDA UDI 0656514f-bd6c-48fe-bc61-124879401a5f 35 fields · synced May 30, 2026