Disposable Plastic Sleeve
by Guangzhou Jaan Medical Co., Ltd
Ref JA-02027Model JA-02020, JA-02021, JA-02022, JA-02023, JA-02024, JA-02025, JA-02026, JA-02027, JA-02028, JA-02029, JA-02030, JA-02031, JA-02032, JA-02033, JA-02034, JA-02035
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 | Number697189549DPSEU01AK 06971895490037 | Date26 Apr 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- Withdrawn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 Plastic Sleeve
- Model / Reference
- JA-02020, JA-02021, JA-02022, JA-02023, JA-02024, JA-02025, JA-02026, JA-02027, JA-02028, JA-02029, JA-02030, JA-02031, JA-02032, JA-02033, JA-02034, JA-02035
- Primary DI / UDI-DI
- 06971895490037
- Basic UDI-DI
- 697189549DPSEU01AK
- EMDN Code
- T030102 Cover sheaths, instruments and equipments
- Device Class
- Class I
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000041648
- 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