EXEL Aluminum Hub Needles 16G X 5/8"
by Exelint International, Co. 2 variants
Ref 26455
Active
CE MDD
Valid until
Not listed
FDA recalls
None foundDocuments
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD EUDAMED | NumberB-00020221264555 00020221264555 | Date12 Feb 2024 | StatusActive |
| United States | GUDID listing GUDID | Number00020221264555 | Date16 Mar 2023 | StatusListed |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Generic Name
- Hypodermic needle, single-use
- Model / Ref / Catalog
- 26455
- Primary DI / UDI-DI
- 00020221264555
- Basic UDI-DI
- B-00020221264555
- 510(k) Number
- FDA Product Code
- LHI
- EMDN Code
- A0101010102 Hypodermic syringe needles, w/o safety systems
- GMDN Term
- Hypodermic needle, single-use
- Device Class
- Class IIa EUDAMEDClass II GUDID
- Regulation Number
- 880.5440
- EU market of registration
- Netherlands
- GUDID distribution status
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device Class | Class IIa | Class II |
Manufacturer details
- EUDAMED SRN
- US-MF-000037396
- Authorised representative
- Emergo Europe B.V. NL-AR-000000116
From the manufacturer
Manufacturer's product page: Aluminum Hub
Other devices from Exelint International, Co.
Properties
Other properties (17)
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Measuring Function: No
- Incorporates Medicinal Product: No
- Prescription Use: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No
- Manufacturing Date: No