Dentsleeve Reusable Catheter
by Mui Scientific, Division of H&A Mui Enterprises Inc. EUDAMED
Active
Ref CE4-1323
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number28620121250-03 | Date9 Mar 2026 | StatusExpiring |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
- 28620121250-03 Issued
Quality management system EU MDR
- Notified body
- Intertek Medical Notified Body AB 2862
- Issued
- 9 Mar 2026
- Expires
- 18 Jan 2027
Specification
- Device Name
- Dentsleeve Reusable Catheter
- Model / Reference
- CE4-1323
- Primary DI / UDI-DI
- 00678467508034
- Basic UDI-DI
- 0678467DENTSLEEVEE9
- EMDN Code
- G0301010101 Oesophageal balloon catheters, low pressure
- Device Class
- Class IIa
- Market of Registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- CA-MF-000016542
- Authorised representative
- Advena Limited MT-AR-000000234
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Properties
Show 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