Hogen Spitze Endo
by C-K Dental Ind.co., Ltd. South Korea EUDAMED
Ref ED30-32-DModel Half Cut, Single Side Vent, Double Side Vent, Blunt End Open
EMDN A010602
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number88000445ED1631ZM | Date20 May 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Certificates
- KR24/00000049 Issued
Quality management system EU MDR
- Notified body
- Notified body 1639
- Issued
- 24 Jun 2024
- Expires
- 24 Jun 2029
Specification
- Device Name
- Sterile single use endodontic irrigation needles
- Model / Reference
- Half Cut, Single Side Vent, Double Side Vent, Blunt End Open, ED30-32-D
- Primary DI / UDI-DI
- 08800044504210
- Basic UDI-DI
- 88000445ED1631ZM
- EMDN Code
- A010602 Dental irrigation needles
- Device Class
- Class IIa
- Market of Registration
- Bulgaria
Manufacturer details
- EUDAMED SRN
- KR-MF-000022929
- Authorised representative
- Obelis s.a. BE-AR-000000106
Other devices from C-K Dental Ind.co., Ltd.
Properties & raw data
Show properties, registry sources and raw records
Other properties (12)
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
Sources (1)
- EUDAMED 883951e7-594e-4611-b148-c009fb05a111