AmLUJECT DENTAL NDL. 25G X 32MM LONG
Ref 90060
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-00020221900606 00020221900606 | Date21 Feb 2024 | StatusActive |
| United States | GUDID listing GUDID | Number00020221900606 | Date27 Nov 2022 | 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- Withdrawn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
- Trade Name
- AmLUJECT DENTAL NDL. 25G X 32MM LONG EUDAMEDAccuject Dental Needles 25G Long GUDID
- Generic Name
- Dental syringe needle, single-use
- Device Name
- Dental Needle
- Model / Ref / Catalog
- 90060, 900605
- Description
- 900605 ; ACCUJECT DENTAL NDL. 25GX32MM LONG, 100/BX, 1000/CS, 6CS/CRTN
- Primary DI / UDI-DI
- 00020221900606
- Basic UDI-DI
- B-00020221900606
- 510(k) Number
- FDA Product Code
- DZM
- EMDN Code
- A010699 Dentistry needles and kits - other
- GMDN Term
- Dental syringe needle, single-use
- Device Class
- Class IIa EUDAMEDClass I GUDID
- Regulation Number
- 872.4730
- EU market of registration
- Belgium
- GUDID distribution status
- In Commercial Distribution
- Size
- Needle Gauge — 25 GaugeLength — 32 Millimeter
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device Class | Class IIa | Class I |
Manufacturer details
- EUDAMED SRN
- US-MF-000037396
- Authorised representative
- Emergo Europe B.V. NL-AR-000000116
Other devices from Exelint International, Co.
Properties
Other properties (16)
- 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
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No
- Manufacturing Date: No