Identity
- Device Name
- Silicone Applicators EUDAMED
- Model / Reference
- 40415 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260649160657 EUDAMED
- Basic UDI-DI
- 426064916404XXU6 EUDAMED
- EMDN Code
- Z129099 VARIOUS INSTRUMENTS FOR FUNCTIONAL EXPLORATION AND THERAPEUTIC INTERVENTIONS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Fixture/appliance dental drill bit, reusable
Silicone Applicators by Laserneedle GmbH — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Fixture/appliance dental drill bit, reusable.
- Hahn — PRISMATIK DENTALCRAFT, INC. · Class I
- Neodent — JJGC Indústria e Comércio de Materiais Dentários S/A. · Class I
- Bone Compaction Drill — OSSTEM IMPLANT Co., Ltd. · Class I
- Prima Plus — Keystone Dental Inc. · Class I
- FTN Tapered Drill — DIO Corporation · Class I
- Prima — Keystone Dental Inc. · Class I
- Twist Drill — OSSTEM IMPLANT Co., Ltd. · Class I
- Stopper Drill — Megagen Implant Co. Ltd · Class I
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 426064916404XXU6 | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Laserneedle GmbH
- EUDAMED SRN
- DE-MF-000023539
Sources (1)
- EUDAMED a70c2fdb-f942-4bfd-9fef-6d3f0be9aef6 61 fields · synced Jun 18, 2026