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EXEL COMFORT POINT INSULIN PEN NDL 31G(0, 25)x1/3"(8mm)
EUDAMEDClass IIa (EU MDR)
Ref 26005Ref 26004
Identity
- Trade Name
- EXEL COMFORT POINT INSULIN PEN NDL 31G(0,25)x1/3"(8mm) EUDAMEDEXEL COMFORT POINT INSULIN PEN NDL 31G(0,25)x1/4"(6mm) EUDAMED
- Device Name
- Insulin Pen Needle EUDAMED
- Model / Reference
- 26005 EUDAMED26004 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00020221260052 EUDAMED00020221260045 EUDAMED
- Basic UDI-DI
- B-00020221260052 EUDAMEDB-00020221260045 EUDAMED
- EMDN Code
- A0101010202 HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
EXEL COMFORT POINT INSULIN PEN NDL 31G(0, 25)x1/3"(8mm) by Exelint International, Co. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00020221260052 | 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 a6f070b6-692e-43a1-89e5-4383292b45b6 61 fields · synced Oct 6, 2026
- EUDAMED b68404eb-df5e-4b26-bcc8-d14dac3d5418 61 fields · synced May 19, 2026