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PrimaDent Ject+Dental Needles 30G/S (0.3 x 16mm)
EUDAMEDClass IIa (EU MDR)
Ref 6130SO
by Spident
Identity
- Trade Name
- PrimaDent Ject+Dental Needles 30G/S (0.3 x 16mm) EUDAMED
- Device Name
- SPIDENT NOP EUDAMED
- Model / Reference
- 6130SO EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809911115825 EUDAMED
- Basic UDI-DI
- B-08809911115825 EUDAMED
- EMDN Code
- A010699 DENTISTRY NEEDLES AND KITS - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Bulgaria EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
PrimaDent Ject+Dental Needles 30G/S (0.3 x 16mm) by Spident — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08809911115825 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Spident
- EUDAMED SRN
- KR-MF-000008691
- Authorised Representative
- AR Experts B.V. NL-AR-000023989
Sources (1)
- EUDAMED 04cb4c5a-f42f-40b3-a96d-7a2d1b6701ca 61 fields · synced Jul 13, 2026