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EXEL AmLUJECT DENTAL NDL. 27G X 21MM SHORT
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref JP-MF-000026759Model 26558
Identity
- Trade Name
- EXEL AmLUJECT DENTAL NDL. 27G X 21MM SHORT EUDAMEDEXEL SuperJect Dental Needle, 27G Short EUDAMEDEXEL Dental Needle FDA UDI
- Generic Name
- Dental syringe needle, single-use FDA UDI
- Device Name
- Dental Needle EUDAMEDEXEL SuperJect Dental Needle EUDAMED27G SHORT, 100/BX, 1000/CS, 6CS/CRTN FDA UDI
- Model / Reference
- 26558 EUDAMEDFDA UDIJP-MF-000026759 EUDAMED
- Description
- 27G SHORT, 100/BX, 1000/CS, 6CS/CRTN FDA UDI
Identifiers
- Catalog Number
- 26558 FDA UDI
- Primary DI / UDI-DI
- 00020221265583 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00020221265583 EUDAMED20221DNTNDL2657G EUDAMED
- 510(k) Number
- K861150 FDA UDI
- FDA Product Code
- DZM FDA UDI
- EMDN Code
- A010699 DENTISTRY NEEDLES AND KITS - OTHER EUDAMEDA010601 CARPULE NEEDLES EUDAMED
- GMDN Term
- Dental syringe needle, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.4730 FDA UDI
- Market of Registration
- Belgium 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
Yes
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 AmLUJECT DENTAL NDL. 27G X 21MM SHORT by Exelint International, Co. — Class IIa — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID
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-00020221265583 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-00020221265583 | 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 c2befbed-00aa-458b-a4ce-386475ca55d8 61 fields · synced Oct 6, 2026
- FDA UDI e371d621-862a-4afa-be70-d3befc10a5d0 36 fields · synced May 30, 2026
- EUDAMED 2db18148-6218-403c-b5db-89519e0ec074 61 fields · synced Oct 6, 2026