Stool
by Kunshan Wecan Medical Equipment Co., Ltd 4 variants
Ref WK-OS5, WK-OS1Model WK-OS1,WK-OS2,WK-OS3,WK-OS4,WK-OS5,WK-OS6,WK-OS7,WK-OS8,WK-OS9,WK-OS10,WK-OS11,WK-OS12,WK-OS13,WK-OS14,WK-OS15,WK-FS1, WK-FS2, WK-FS3, WK-FS4,WK-FS5,WK-FS6
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 | Number697311360Stool4T | Date19 Jan 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- Withdrawn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
- Stool
- Model / Reference
- WK-OS1, WK-OS2, WK-OS3, WK-OS4, WK-OS5, WK-OS6, WK-OS7, WK-OS8, WK-OS9, WK-OS10, WK-OS11, WK-OS12, WK-OS13, WK-OS14, WK-OS15, WK-FS1, WK-FS2, WK-FS3, WK-FS4, WK-FS5, WK-FS6
- Primary DI / UDI-DI
- 06973113603519, 06973113603502
- Basic UDI-DI
- 697311360Stool4T
- EMDN Code
- V0899 Medical support equipment - other
- Device Class
- Class I
- EU market of registration
- GermanyAustria
Manufacturer details
- EUDAMED SRN
- CN-MF-000039564
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Kunshan Wecan Medical Equipment Co., Ltd
See all devices from Kunshan Wecan Medical Equipment Co., Ltd →
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