← Back to catalogue
EXEL AmLUJECT DENTAL NDL. 27G X 32MM LONG
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref DNT26557Model 26557
Identity
- Trade Name
- EXEL AmLUJECT DENTAL NDL. 27G X 32MM LONG EUDAMEDEXEL SuperJect Dental Needle, 27G Long EUDAMEDEXEL Dental Needle FDA UDI
- Generic Name
- Dental syringe needle, single-use FDA UDI
- Device Name
- Dental Needle EUDAMEDEXEL SuperJect Dental Needle EUDAMED27G LONG, 100/BX, 1000/CS, 6CS/CRTN FDA UDI
- Model / Reference
- 26557 EUDAMEDFDA UDIDNT26557 EUDAMED
- Description
- 27G LONG, 100/BX, 1000/CS, 6CS/CRTN FDA UDI
Identifiers
- Catalog Number
- 26557 FDA UDI
- Primary DI / UDI-DI
- 00020221265576 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00020221265576 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 32MM LONG 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-00020221265576 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-00020221265576 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Exelint International, Co.
- EUDAMED SRN
- US-MF-000037396
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (3)
- EUDAMED 6e893378-6a9e-4ebe-a639-33c79839d58f 61 fields · synced Jul 22, 2026
- FDA UDI cd5ae114-0d45-47d4-a46e-03523c7a7578 36 fields · synced May 30, 2026
- EUDAMED 5ad133b8-de40-401f-9da6-38967c32248b 61 fields · synced Jul 22, 2026