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Cortex stoppers kit- Prime
EUDAMEDClass IIa (EU MDR)
Ref CK-0009, CK-XXXX,CT-XXXX,CM-XXXX, CO-XXXX, MPN-XXXX, MPR-XXXX, MCT-XXXXModel Surgical Tools (Dental Instrument connected to an active device)Ref CK/CM/CO/MCT/MPN-xxxxx
Identity
- Trade Name
- Cortex stoppers kit- Prime EUDAMED
- Device Name
- Surgical Tools (Dental Instrument connected to an active device) EUDAMEDHexagonal/Conical System tools (connected to an active medical device): drivers (for handpiece - motor mount) Drill extender EUDAMED
- Model / Reference
- Surgical Tools (Dental Instrument connected to an active device) EUDAMEDCK-0009, CK-XXXX,CT-XXXX,CM-XXXX, CO-XXXX, MPN-XXXX, MPR-XXXX, MCT-XXXX EUDAMEDCK/CM/CO/MCT/MPN-xxxxx EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07290116660516 EUDAMED
- Basic UDI-DI
- 729011666CORTOOL001CR EUDAMEDB-07290116660516 EUDAMED
- Direct Marketing DI
- 07290116660516 EUDAMED
- EMDN Code
- L159016 DENTAL SURGERY INSTRUMENT KITS, REUSABLE EUDAMEDP01020180 DENTAL IMPLANTS - ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Cyprus EUDAMEDHungary EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Dental/maxillofacial surgical procedure kit, non-medicated, reusable
Cortex stoppers kit- Prime by Cortex Dental Implants Industries Ltd. — Class IIa — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Dental/maxillofacial surgical procedure kit, non-medicated, reusable.
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 729011666CORTOOL001CR | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 729011666CORTOOL001CR | Class IIa | Active |
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Manufacturer
- Manufacturer
- Cortex Dental Implants Industries Ltd.
- EUDAMED SRN
- IL-MF-000010778
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (3)
- EUDAMED 1a92c953-0b39-4b05-9b24-a24d05f0ac85 61 fields · synced Oct 6, 2026
- EUDAMED 85a8b1aa-9c9b-4421-b835-5fc5d67c5f9d 61 fields · synced May 18, 2026
- EUDAMED 1a92c953-0b39-4b05-9b24-a24d05f0ac85-1 61 fields · synced Jun 10, 2026