KJ Implant System
by KJ MEDITECH Co., Ltd. 62 variants
Ref KMT001Model Instrument
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number88002086IFS05H7 08800208605104 | Date20 Jul 2026 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Model / Reference
- Instrument, KMT001
- Primary DI / UDI-DI
- 08800208605104
- Basic UDI-DI
- 88002086IFS05H7
- EMDN Code
- L159016 Dental surgery instrument kits, reusable
- Device Class
- Class I
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- KR-MF-000039683
- Authorised representative
- S.B. Pharma GmbH DE-AR-000005392
Other devices from Kj Meditech Co., Ltd.
Properties
Other properties (12)
- Sterile: No
- Implantable: 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