Identity
- Trade Name
- EXEL 1mL SYR ONLY LUER LOCK EUDAMEDEXEL Disposable Syringe, 1mL Luer Lock Tip EUDAMEDEXEL Syringes FDA UDI
- Generic Name
- General-purpose syringe, single-use FDA UDI
- Device Name
- Syringe only EUDAMEDEXEL Disposable Syringe EUDAMEDSyringe, 1CC, Luer Lock FDA UDI
- Model / Reference
- 26050 EUDAMEDFDA UDI
- Description
- Syringe, 1CC, Luer Lock FDA UDI
Identifiers
- Catalog Number
- 26050 FDA UDI
- Primary DI / UDI-DI
- 00020221260502 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00020221260502 EUDAMED20221SYRONLY263ES EUDAMED
- FDA Product Code
- FMF FDA UDI
- EMDN Code
- A020199 SYRINGES, SINGLE-USE - OTHER EUDAMEDA020102020102 INFUSION AND IRRIGATION SYRINGES, LUER LOCK CONE, 3-PIECE WITHOUT NEEDLE, SINGLE-USE EUDAMED
- GMDN Term
- General-purpose syringe, single-use FDA UDI
Classification
- Device Class
- Class I 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
No
EUDAMEDEUDAMED
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 1mL SYR ONLY LUER LOCK by Exelint International, Co. — Class I — 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-00020221260502 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-00020221260502 | 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 (3)
- EUDAMED 0b084985-4ca2-48d9-810c-d57bb6347887 61 fields · synced Jun 11, 2026
- FDA UDI ae5e063e-c25d-4bbf-b5e9-4fdee294ff6b 34 fields · synced May 30, 2026
- EUDAMED 3e8e7831-6e33-484e-8938-bd3084ad42cf 61 fields · synced Jun 11, 2026