Phoniq Digiclose Hme Filter Phoniq Low Profile Hme Filter
by Sheffmed Limited 5 variants
Ref LAPFT0002
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 | Number506041720PHONIQHMEF-SUUK 05060417204144 | Date16 Apr 2025 | 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- Withdrawn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
- Phoniq Digiclose Hme Filter Phoniq Low Profile Hme Filter
- Model / Reference
- LAPFT0002
- Primary DI / UDI-DI
- 05060417204144
- Basic UDI-DI
- 506041720PHONIQHMEF-SUUK
- EMDN Code
- R01058099 Tracheostomy and laryngectomy cannulas - various accessories
- Device Class
- Class I
- EU market of registration
- Spain
Manufacturer details
- EUDAMED SRN
- GB-MF-000004158
- Authorised representative
- Advena Limited MT-AR-000000234
Other devices from Sheffmed Limited
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