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EXEL ComfortPoint Insulin Syringe - 0.5mL, 31G x 5/16"
EUDAMEDClass IIa (EU MDR)
Ref 26011
Identity
- Trade Name
- EXEL ComfortPoint Insulin Syringe - 0.5mL, 31G x 5/16" EUDAMED
- Device Name
- EXEL ComfortPoint Insulin Syringe EUDAMED
- Model / Reference
- 26011 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10020221260110 EUDAMED
- Basic UDI-DI
- 20221SYRINS26015M EUDAMED
- Unit of Use DI
- 00020221260113 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 - 0.5mL, 31G x 5/16" 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 (1)
- EUDAMED a9870431-bfdb-4743-ab10-a9b3608c2a38 61 fields · synced Oct 6, 2026