Ostomy Bag
by Joyhomecare Medical Instrument Co., Ltd
Ref 2041650Model 2041650、101125、101055、101155、101085、101050、101060、101080、101075、102050、102055、102060、101040、101140、111245、112245、2130045、2030045、2030057、2030070、2039045、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 | Number697591325OBEU01P8 06975913250009 | Date2 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- Withdrawn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
- Ostomy Bag
- Model / Reference
- 2041650、101125、101055、101155、101085、101050、101060、101080、101075、102050、102055、102060、101040、101140、111245、112245、2130045、2030045、2030057、2030070、2039045、etc, 2041650
- Primary DI / UDI-DI
- 06975913250009
- Basic UDI-DI
- 697591325OBEU01P8
- EMDN Code
- A1001010101, A1001010102, A1001010201, A1001010202, A1001020101, A1001020102, A100104, A100199
- Device Class
- Class I
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000041013
- 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