Electrosurgical Vessel Sealer/Divider
by Affacare Medical (Beijing) Co., Ltd. EUDAMED
Active
Ref AH-16319-23Model AH-16319-23, AH-16319-37, AH-16319-44, AH-163XP-23S, AH-163XP-37S, AH-163XP-44S, AH-163XP-23L, AH-163XP-37L, AH-163XP-44L, AH-1637-21
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number6970950282b014B3 | Date30 Sep 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Electrosurgical Vessel Sealer/Divider
- Model / Reference
- AH-16319-23, AH-16319-37, AH-16319-44, AH-163XP-23S, AH-163XP-37S, AH-163XP-44S, AH-163XP-23L, AH-163XP-37L, AH-163XP-44L, AH-1637-21
- Primary DI / UDI-DI
- 06970950281597
- Basic UDI-DI
- 6970950282b014B3
- EMDN Code
- K0201010201,K0201010202
- Device Class
- Class IIb
- Market of Registration
- Ireland
Manufacturer details
- EUDAMED SRN
- CN-MF-000025388
- Authorised representative
- Prolinx GmbH DE-AR-000005129
Other devices from Affacare Medical (Beijing) Co., Ltd.
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