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Phoniq Digiclose Hme Filter Phoniq Low Profile Hme Filter
EUDAMEDClass I (EU MDR)
Ref LAPFT0004Ref LAPFT0002Ref LAPFT0003
Identity
- Device Name
- PHONIQ DIGICLOSE HME FILTER PHONIQ LOW PROFILE HME FILTER EUDAMED
- Model / Reference
- LAPFT0004 EUDAMEDLAPFT0002 EUDAMEDLAPFT0003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060417204168 EUDAMED05060417204144 EUDAMED05060417204151 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 (3)
- EUDAMED f8c7e90b-8fd4-44fe-a936-c5bc8fad5be3 61 fields · synced Jul 24, 2026
- EUDAMED 9aa1b780-13f4-42b9-be2b-5979869a4756 61 fields · synced May 18, 2026
- EUDAMED e484c81c-6aea-4e83-8c6d-dee71e1d754d 61 fields · synced May 19, 2026