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EXEL ComfortPoint Insulin Syringe - 0.3mL, 30G x 1/2"
EUDAMEDClass IIa (EU MDR)
Ref 26019Ref 26029
Identity
- Trade Name
- EXEL ComfortPoint Insulin Syringe - 0.3mL, 30G x 1/2" EUDAMEDEXEL ComfortPoint Insulin Syringe EUDAMED
- Device Name
- EXEL ComfortPoint Insulin Syringe EUDAMED
- Model / Reference
- 26019 EUDAMED26029 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10020221260196 EUDAMED10020221260295 EUDAMED
- Basic UDI-DI
- 20221SYRINS26015M EUDAMED
- Unit of Use DI
- 00020221260199 EUDAMED00020221260298 EUDAMED
- EMDN Code
- A02010601 INSULIN SYRINGES WITH FIXED NEEDLE, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Ireland 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
EXEL ComfortPoint Insulin Syringe - 0.3mL, 30G x 1/2" by Exelint International, Co. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 20221SYRINS26015M | 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 47cc9c96-2640-41c1-85bb-93558299172d 61 fields · synced Oct 6, 2026
- EUDAMED 98d6a309-6391-4da5-b6e3-53f79d9f3389 61 fields · synced May 18, 2026