Identity
- Trade Name
- EXEL HYPO NDL 21G X 1-1/4 EUDAMEDEXEL Hypodermic Needle 21G x 1-1/4" EUDAMEDEXEL HYPO NDL 21GX1-1/4" FDA UDI
- Generic Name
- Hypodermic needle, single-use FDA UDI
- Device Name
- Hypodermic Needle EUDAMEDEXEL Hypodermic Needle EUDAMEDEXEL HYPO NDL 21GX1-1/4", 100/BX, 2000/CS, 5CS/CRTN FDA UDI
- Model / Reference
- 26415 EUDAMEDFDA UDI
- Description
- EXEL HYPO NDL 21GX1-1/4", 100/BX, 2000/CS, 5CS/CRTN FDA UDI
Identifiers
- Catalog Number
- 26415 FDA UDI
- Primary DI / UDI-DI
- 00020221264159 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00020221264159 EUDAMED20221HYPONDL264VZ 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
- Netherlands EUDAMEDAustria 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 Hypo Ndl 21g X 1-1/4 by Exelint International, Co. — Class IIa — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-00020221264159 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-00020221264159 | 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 bab2272e-9849-4d94-99d1-b5627388c1b9 61 fields · synced Oct 6, 2026
- EUDAMED b66b586b-f24d-43a1-bca4-c8666a03dd65 61 fields · synced May 18, 2026
- FDA UDI d8839158-2ce3-4495-a578-cdf197940919 36 fields · synced May 30, 2026