Identity
- Trade Name
- EXEL 1/2mL INS 28GX1/2" EUDAMEDFDA UDI
- Generic Name
- Insulin syringe/needle, basic FDA UDI
- Device Name
- Insulin Syringe EUDAMEDEXEL 1/2mL INS 28GX1/2" BULK PAK; STERILE; 10/POLY BAG, 4500/CRTN FDA UDI
- Model / Reference
- 26032 EUDAMEDFDA UDI
- Description
- EXEL 1/2mL INS 28GX1/2" BULK PAK; STERILE; 10/POLY BAG, 4500/CRTN FDA UDI
Identifiers
- Catalog Number
- 26032 FDA UDI
- Primary DI / UDI-DI
- 00020221260328 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00020221260328 EUDAMED
- 510(k) Number
- K861153 FDA UDI
- FDA Product Code
- FMF FDA UDI
- EMDN Code
- A02010601 INSULIN SYRINGES WITH FIXED NEEDLE, SINGLE-USE EUDAMED
- GMDN Term
- Insulin syringe/needle, basic FDA UDI
Classification
- Device Class
- Class IIa 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
Yes
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 1/2mL INS 28GX1/2" by Exelint International, Co. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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-00020221260328 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | 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 f7e648c2-c4ca-423c-b42a-a630a0ef6657 61 fields · synced Jun 18, 2026
- FDA UDI 623e23b3-9658-4d84-871b-a6ef8d57db6a 36 fields · synced May 30, 2026