Identity
- Trade Name
- EMTONE EUDAMED
- Model / Reference
- EMTONE EUDAMEDA784.201 EUDAMED
Identifiers
- Primary DI / UDI-DI
- B108784POEMTMEU00 EUDAMED
- Basic UDI-DI
- ++B108084POEUZ6 EUDAMED
- Direct Marketing DI
- B108784POEMTMEU00 EUDAMED
- EMDN Code
- X0402,X0599,Z12069099 EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Northern Ireland 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
Emtone by BTL Industries Limited — Class IIb — 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 | ++B108084POEUZ6 | Class IIb | Active |
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Manufacturer
- Manufacturer
- BTL Industries Limited
- EUDAMED SRN
- GB-MF-000034894
- Authorised Representative
- BTL ITALIA S.r.l. IT-AR-000020508
Sources (1)
- EUDAMED 69048dab-965b-489d-88e6-80e0f9157bc6 61 fields · synced Jun 18, 2026