Ace Ject
by C-K Dental Ind.co., Ltd. South Korea EUDAMED
Ref 30-16-I
EMDN A010601
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number88000445DN25314T | Date18 May 2025 | 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 dental needles
- Model / Reference
- 30-16-I
- Primary DI / UDI-DI
- 08800044511980
- Basic UDI-DI
- 88000445DN25314T
- EMDN Code
- A010601 Carpule needles
- Device Class
- Class IIa
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 (11)
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Measuring Function: No
- Incorporates Medicinal Product: No
Sources (1)
- EUDAMED 2f24fd37-3192-4de5-89d0-291fb9b4ce65