Disposable Oral Catheter Device
by Shangji Medical Technology (Zhejiang) Co., Ltd
Ref SJ-KQDG-I-22Model SJ-KQDG-I-22, SJ-KQDG-I-25, SJ-KQDG-I-29, SJ-KQDG-I-32; SJ-KQDG-Ⅱ-22, SJ-KQDG-Ⅱ-25, SJ-KQDG-Ⅱ-29, SJ-KQDG-Ⅱ-32; SJ-KQDG-Ⅲ-22, SJ-KQDG-Ⅲ-25, SJ-KQDG-Ⅲ-29, SJ-KQDG-Ⅲ-32; SJ-KQDG-Ⅳ-22, SJ-KQDG-Ⅳ-25, SJ-KQDG-Ⅳ-29, SJ-KQDG-Ⅳ-32; etc
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697546058SJDOCDW6 06975460580000 | Date15 May 2024 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Disposable Oral Catheter Device
- Model / Reference
- SJ-KQDG-I-22, SJ-KQDG-I-25, SJ-KQDG-I-29, SJ-KQDG-I-32, SJ-KQDG-Ⅱ-22, SJ-KQDG-Ⅱ-25, SJ-KQDG-Ⅱ-29, SJ-KQDG-Ⅱ-32, SJ-KQDG-Ⅲ-22, SJ-KQDG-Ⅲ-25, SJ-KQDG-Ⅲ-29, SJ-KQDG-Ⅲ-32, SJ-KQDG-Ⅳ-22, SJ-KQDG-Ⅳ-25, SJ-KQDG-Ⅳ-29, SJ-KQDG-Ⅳ-32, etc
- Primary DI / UDI-DI
- 06975460580000
- Basic UDI-DI
- 697546058SJDOCDW6
- EMDN Code
- Q03040101 Ear drainage and ventilation catheters and cannulas
- Device Class
- Class I
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000041573
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
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