Identity
- Device Name
- VOICELINE VOICE PROTHESIS CLEANING BRUSH EUDAMED
- Model / Reference
- LAPCB0003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060417204120 EUDAMED
- Basic UDI-DI
- 506041720INSITUCLEAN-SUBN EUDAMED
- EMDN Code
- R9099 RESPIRATORY AND ANAESTHESIA DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
Yes
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
Category: Pulmonary function analysis system, adult
Voiceline Voice Prothesis Cleaning Brush by Sheffmed Limited — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 506041720INSITUCLEAN-SUBN | 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 caa30e3f-81aa-4c99-ab52-843bd7d04a86 61 fields · synced Jul 9, 2026