Fahnestock Knife with Plastic Handle
by Mark One Surgical EUDAMED
Active
Ref D-119-822Model Knives
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number896110404KNIVES/CLASSI6E | Date17 Jun 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Specification
- Device Name
- Gingivectomy Knives Orban Fig. 1
- Model / Reference
- Knives, D-119-822
- Primary DI / UDI-DI
- 08961104044333
- Basic UDI-DI
- 896110404KNIVES/CLASSI6E
- EMDN Code
- L159013 Dental spatulas, reusable
- Device Class
- Class I
- Market of Registration
- Spain
Manufacturer details
- EUDAMED SRN
- PK-MF-000031202
- Authorised representative
- KHANG BAO INTERNATIONAL KFT HU-AR-000034102
Other devices from Mark One Surgical
Properties
Other properties (13)
- Sterile: No
- 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