Identity
- Trade Name
- EXEL CURVED TIP 10ml SYRINGE EUDAMEDFDA UDIEXEL Curved Tip Syringe EUDAMED
- Generic Name
- Irrigation syringe FDA UDI
- Device Name
- Curved Tip Syringe EUDAMEDEXEL Curved Tip Syringe EUDAMEDEXEL CURVED TIP 10ml SYRINGE; BULK, NON-STERILE, 50PC/BX, 500PC/CS, 2CS/CRTN FDA UDI
- Model / Reference
- 26267 EUDAMEDFDA UDI
- Description
- EXEL CURVED TIP 10ml SYRINGE; BULK, NON-STERILE, 50PC/BX, 500PC/CS, 2CS/CRTN FDA UDI
Identifiers
- Catalog Number
- 26267 FDA UDI
- Primary DI / UDI-DI
- 00020221262674 EUDAMEDFDA UDI10020221262671 EUDAMED
- Basic UDI-DI
- B-00020221262674 EUDAMED20221CRVTIP262F2 EUDAMED
- Unit of Use DI
- 00020221262674 EUDAMED
- 510(k) Number
- K861153 FDA UDI
- FDA Product Code
- FMF FDA UDI
- EMDN Code
- A02010299 INFUSION AND IRRIGATION SYRINGES - OTHER EUDAMED
- GMDN Term
- Irrigation syringe 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
No
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
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 CURVED TIP 10ml SYRINGE 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-00020221262674 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-00020221262674 | 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 a1273da0-c419-48b5-bc68-30e1d0eac405 61 fields · synced Oct 6, 2026
- FDA UDI 9641a2ba-ecf6-432d-a941-42591eccc829 36 fields · synced May 30, 2026
- EUDAMED 0b0029c5-3f1d-4e36-8de9-44e065e8cd19 61 fields · synced Jul 14, 2026