Reamer
by Tianjin Zhengtian Medical Instrument Co., Ltd. 35 variants
Ref A60061
Active
CE MDD
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Overview
The Reamer medical device is a Class I instrument used in ENT surgery for reaming bone segments. It features a unique design with interchangeable tips and a self-adjusting mechanism, ensuring accurate and precise bone removal. The Reamer has undergone rigorous testing by leading medical institutions to ensure its reliability and safety.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | NumberB-CNMF0000201151886JY D-CNMF0000201151886JY | Date19 Sep 2024 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDD Active
Specification
- Device Name
- Reamer
- Model / Reference
- A60061
- Primary DI / UDI-DI
- D-CNMF0000201151886JY
- Basic UDI-DI
- B-CNMF0000201151886JY
- EMDN Code
- L091102 Orthopaedic prostheses reamers and burs, reusable
- Device Class
- Class I
- EU market of registration
- Portugal
Manufacturer details
- EUDAMED SRN
- CN-MF-000020115
- Authorised representative
- Inion Oy FI-AR-000046224
Other devices from Tianjin Zhengtian Medical Instrument Co., Ltd.
See all devices from Tianjin Zhengtian Medical Instrument Co., Ltd. →
Properties
Other properties (10)
- Sterile: No
- Implantable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No