Identity
- Trade Name
- EXEL Hypodermic Needle 22G x 1-1/4" EUDAMEDEXEL HYPO NDL 22G X 1-1/4 EUDAMEDEXEL HYPO NDL 22GX1-1/4" FDA UDI
- Generic Name
- Hypodermic needle, single-use FDA UDI
- Device Name
- EXEL Hypodermic Needle EUDAMEDHypodermic Needle EUDAMEDEXEL HYPO NDL 22GX1-1/4", 100/BX, 2000/CS, 5CS/CRTN FDA UDI
- Model / Reference
- 26413 EUDAMEDFDA UDI
- Description
- EXEL HYPO NDL 22GX1-1/4", 100/BX, 2000/CS, 5CS/CRTN FDA UDI
Identifiers
- Catalog Number
- 26413 FDA UDI
- Primary DI / UDI-DI
- 00020221264135 EUDAMEDFDA UDI
- Basic UDI-DI
- 20221HYPONDL264VZ EUDAMEDB-00020221264135 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 22G x 1-1/4" 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 ff19a9fb-eca3-4455-9f96-0970e5b80e59 61 fields · synced Jun 17, 2026
- EUDAMED 954b25dc-ae88-4711-88f4-564d2539ffa2 61 fields · synced May 18, 2026
- FDA UDI 5faa723c-13bf-4c55-959d-c44d8403e4ba 36 fields · synced May 27, 2026