Identity
- Trade Name
- EXEL Hypodermic Needle 26Gx3/8" EUDAMEDEXEL Hypodermic Needle 26G x 3/8" EUDAMEDEXEL HYPO NDL 26GX3/8" FDA UDI
- Generic Name
- Hypodermic needle, single-use FDA UDI
- Device Name
- EXEL Hypodermic Needle EUDAMEDHypodermic Needle EUDAMEDEXEL HYPO NDL 26GX3/8", 100/BX, 2000/CS, 5CS/CRTN FDA UDI
- Model / Reference
- 26401 EUDAMEDFDA UDI
- Description
- EXEL HYPO NDL 26GX3/8", 100/BX, 2000/CS, 5CS/CRTN FDA UDI
Identifiers
- Catalog Number
- 26401 FDA UDI
- Primary DI / UDI-DI
- 00020221264012 EUDAMEDFDA UDI
- Basic UDI-DI
- 20221HYPONDL264VZ EUDAMEDB-00020221264012 EUDAMED
- 510(k) Number
- K861153 FDA UDI
- FDA Product Code
- FMF FDA UDI
- EMDN Code
- A0101010102 HYPODERMIC SYRINGE NEEDLES, W/O SAFETY SYSTEMS EUDAMED
- GMDN Term
- Hypodermic needle, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 880.5860 FDA UDI
- Market of Registration
- Austria EUDAMEDNetherlands 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
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
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 Hypodermic Needle 26Gx3/8" by Exelint International, Co. — Class IIa — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 20221HYPONDL264VZ | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 20221HYPONDL264VZ | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Exelint International, Co.
- EUDAMED SRN
- US-MF-000037396
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (3)
- EUDAMED faff0f05-7043-45c7-b202-1b288af5f2bf 61 fields · synced Jul 13, 2026
- EUDAMED 5fe73a4f-6b8d-48e7-8378-8ae4bc1c1108 61 fields · synced May 17, 2026
- FDA UDI c33d7922-c10a-4589-860b-62866affe146 36 fields · synced May 30, 2026