Identity
- Trade Name
- EXEL DNTL NDL 30G LONG EUDAMEDEXEL SuperJect Dental Needle, 30G Long EUDAMEDEXEL Dental Needle FDA UDI
- Generic Name
- Dental syringe needle, single-use FDA UDI
- Device Name
- Dental Needle EUDAMEDEXEL SuperJect Dental Needle EUDAMED30G LONG, 100/BX, 1000/CS, 6CS/CRTN FDA UDI
- Model / Reference
- 26562 EUDAMEDFDA UDI
- Description
- 30G LONG, 100/BX, 1000/CS, 6CS/CRTN FDA UDI
Identifiers
- Catalog Number
- 26562 FDA UDI
- Primary DI / UDI-DI
- 00020221265620 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00020221265620 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 Dntl Ndl 30g Long by Exelint International, Co. — Class IIa — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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-00020221265620 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-00020221265620 | 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 91311ecf-9379-4064-b489-a51cbc7314e5 61 fields · synced Jul 12, 2026
- FDA UDI 0ae9529c-d5a9-41f3-ae8a-0f07691192ac 36 fields · synced May 30, 2026
- EUDAMED 32ccc9be-465a-4f84-89fd-8b0fef0e1ec4 61 fields · synced Jun 19, 2026