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Phoniq Digiclose Hme Filter Phoniq Low Profile Hme Filter
EUDAMEDClass I (EU MDR)
Ref LAPFT0001
Identity
- Device Name
- PHONIQ DIGICLOSE HME FILTER PHONIQ LOW PROFILE HME FILTER EUDAMED
- Model / Reference
- LAPFT0001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060417204137 EUDAMED
- Basic UDI-DI
- 506041720PHONIQHMEF-SUUK EUDAMED
- EMDN Code
- R01058099 TRACHEOSTOMY AND LARYNGECTOMY CANNULAS - VARIOUS ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Phoniq Digiclose Hme Filter Phoniq Low Profile Hme Filter by Sheffmed Limited — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 506041720PHONIQHMEF-SUUK | Class I | Active |
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Manufacturer
- Manufacturer
- Sheffmed Limited
- EUDAMED SRN
- GB-MF-000004158
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED 7792a7c7-d5b4-40cd-9eaa-27590a951f4a 61 fields · synced Jun 18, 2026