Ostomy Bag(Colostomy Bag or Urine Bag or Water Proof Bag or Dry Bag)
by Wenzhou Celecare Medical lnstruments Co., Ltd. 5 variants
Ref MDR
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 | Number69704372426114XD 06970437240796 | Date1 Jun 2022 | 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- Withdrawn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(Colostomy Bag or Urine Bag or Water Proof Bag or Dry Bag)
- Model / Reference
- MDR
- Primary DI / UDI-DI
- 06970437240796
- Basic UDI-DI
- 69704372426114XD
- EMDN Code
- A1001010101 One-piece colostomy bags for non-retracted stoma, flat, w/o tissue cover
- Device Class
- Class I
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000024264
- Authorised representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Other devices from Wenzhou Celecare Medical lnstruments Co., Ltd.
See all devices from Wenzhou Celecare Medical lnstruments 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