← Back to catalogue
EXEL 1mL AMBER SYR ONLY LUER SLIP W/ TIP CAP
EUDAMEDFDA UDIClass I (EU MDR)
Ref 26038
Identity
- Trade Name
- EXEL 1mL AMBER SYR ONLY LUER SLIP W/ TIP CAP EUDAMEDFDA UDI
- Generic Name
- General-purpose syringe, single-use FDA UDI
- Device Name
- Syringe only EUDAMEDEXEL 1mL AMBER SYR ONLY LUER SLIP W/ TIP CAP; 100/BX, 1000/CS FDA UDI
- Model / Reference
- 26038 EUDAMEDFDA UDI
- Description
- EXEL 1mL AMBER SYR ONLY LUER SLIP W/ TIP CAP; 100/BX, 1000/CS FDA UDI
Identifiers
- Catalog Number
- 26038 FDA UDI
- Primary DI / UDI-DI
- 00020221260380 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00020221260380 EUDAMED
- 510(k) Number
- K861153 FDA UDI
- FDA Product Code
- FMF FDA UDI
- EMDN Code
- W01029004 COATED TUBES AND BEADS (UNASSIGNABLE) (IC) 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 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
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 1mL AMBER SYR ONLY LUER SLIP W/ TIP CAP by Exelint International, Co. — Class I — MDD, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00020221260380 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | 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 fa894c22-c7d6-4aeb-9a50-42a7f07dde30 61 fields · synced Jul 15, 2026
- FDA UDI 14e1d3f1-874f-4d75-9e80-d73f6dbd11dd 36 fields · synced May 30, 2026