Suction system
by Guangzhou Ajax Medical Equipment Co., Ltd. EUDAMED
Active
Ref 06971608312731Model SP1000, SP3000, SP5000, SP3000+, SP5000+, V3, V5, V7, V10, V14, SV300, SV400, SV600, SV800, SV1000, PV100
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697160831SuctionSystemR7 | Date10 Mar 2025 | 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- Withdrawn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
- Suction system
- Model / Reference
- SP1000, SP3000, SP5000, SP3000+, SP5000+, V3, V5, V7, V10, V14, SV300, SV400, SV600, SV800, SV1000, PV100, 06971608312731
- Primary DI / UDI-DI
- 06971608312731
- Basic UDI-DI
- 697160831SuctionSystemR7
- Direct Marketing DI
- 06971608312731
- EMDN Code
- A0601010199 Drainage systems with predefined suction - other
- Device Class
- Class I
- Market of Registration
- Romania
Manufacturer details
- EUDAMED SRN
- CN-MF-000016044
- Authorised representative
- MedNet EC-REP GmbH DE-AR-000000002
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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