Ultrasonic Surgical Shears
by Affacare Medical (Beijing) Co., Ltd. EUDAMED
Active
Ref AH-639-T-CModel AH-639-O-C, AH-639-L-C, AH-639-S-C, AH-639-T-C
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number6970950282b001AS | Date2 Mar 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Specification
- Model / Reference
- AH-639-O-C, AH-639-L-C, AH-639-S-C, AH-639-T-C
- Primary DI / UDI-DI
- 06970950280682
- Basic UDI-DI
- 6970950282b001AS
- Direct Marketing DI
- 06970950280682
- EMDN Code
- K0202010102 Laparoscopic and thoracoscopic ultrasonic surgery scissors, single-use
- Device Class
- Class IIb
- Market of Registration
- Italy
Manufacturer details
- EUDAMED SRN
- CN-MF-000025388
- Authorised representative
- Prolinx GmbH DE-AR-000005129
Other devices from Affacare Medical (Beijing) Co., Ltd.
Properties
Show properties
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