Identity
- Trade Name
- EXEL IV CATH 18GX2" EUDAMEDEXEL Safelet IV Catheter, 18G x 2” EUDAMED
- Device Name
- IV Catheter EUDAMEDEXEL Safelet IV Catheter EUDAMED
- Model / Reference
- 26738 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00020221267389 EUDAMED
- Basic UDI-DI
- B-00020221267389 EUDAMED20221IVCAT267ZT EUDAMED
- EMDN Code
- A018003 NEEDLE INTRODUCERS EUDAMEDC0101010102 PERIPHERAL I.V. CATHETERS, W/O SAFETY SYSTEMS, W/O INJECTION VALVES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands EUDAMEDAustria EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Exel Iv Cath 18gx2" by Exelint International, Co. — Class IIa — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-00020221267389 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-00020221267389 | Class IIa | Active |
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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 961f6daf-8183-4b57-bf70-3b0a340dad56 61 fields · synced Jun 19, 2026
- EUDAMED 0a0ff614-144f-4f97-97ce-a73f506aec89 61 fields · synced Jun 19, 2026