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EXEL Aluminum Hub Needles 16G X 5/8"
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 26455B
Identity
- Trade Name
- EXEL Aluminum Hub Needles 16G X 5/8" EUDAMEDEXEL Aluminum Hub Needles 16G X 5/8", B Bevel FDA UDI
- Generic Name
- Hypodermic needle, single-use FDA UDI
- Device Name
- Aluminum Hub Needle EUDAMEDEXEL Aluminum Hub Needles 16G X 5/8", B Bevel; 100/BX, 1000/CS, 4CS/CRTN FDA UDI
- Model / Reference
- 26455B EUDAMEDFDA UDI
- Description
- EXEL Aluminum Hub Needles 16G X 5/8", B Bevel; 100/BX, 1000/CS, 4CS/CRTN FDA UDI
Identifiers
- Catalog Number
- 26455B FDA UDI
- Primary DI / UDI-DI
- 00020221064551 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00020221064551 EUDAMED
- 510(k) Number
- K101309 FDA UDI
- FDA Product Code
- LHI 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
- 880.5440 FDA UDI
- Market of Registration
- Belgium 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 Aluminum Hub Needles 16G X 5/8" 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-00020221064551 | 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 (2)
- EUDAMED 94ba9c91-3ece-4e97-bfaf-1b678781d6b5 61 fields · synced Jun 19, 2026
- FDA UDI 1e340b9e-c590-4aa9-9db1-726fb5bc5652 36 fields · synced May 30, 2026