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Communicator
EUDAMEDClass I (EU MDR)
Ref 2409Model CommunicatorRef 4200Ref 2402Ref 7075Ref 7083Ref 2391Ref 4040Ref 2500BRef 4202Ref 8151Ref 3051Ref 4055
Identity
- Trade Name
- Communicator EUDAMED
- Device Name
- Talkable 2 EUDAMED
- Model / Reference
- Communicator EUDAMED2409 EUDAMED4200 EUDAMED2402 EUDAMED7075 EUDAMED7083 EUDAMED2391 EUDAMED4040 EUDAMED2500B EUDAMED4202 EUDAMED8151 EUDAMED3051 EUDAMED4055 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850079998193 EUDAMED00850079998315 EUDAMED00850079998124 EUDAMED00850079998278 EUDAMED00850079998285 EUDAMED00850079998179 EUDAMED00850079998230 EUDAMED00850079998308 EUDAMED00850079998322 EUDAMED00850079998247 EUDAMED00850079998209 EUDAMED00850079998414 EUDAMED
- Basic UDI-DI
- 850079998CommunicatorAW EUDAMED
- EMDN Code
- Y99 DEVICES FOR PERSONS WITH DISABILITIES NOT INCLUDED IN OTHER CATEGORIES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
Communicator by Enabling Devices Inc. — 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 | 850079998CommunicatorAW | Class I | Active |
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Manufacturer
- Manufacturer
- Enabling Devices Inc.
- EUDAMED SRN
- US-MF-000049616
- Authorised Representative
- European Healthcare & Device Solutions Ltd. IE-AR-000003999
Sources (12)
- EUDAMED 80790512-1e1d-4d61-bc1a-ac0d2fc64406 61 fields · synced Oct 6, 2026
- EUDAMED 3dfbdac5-c801-43cd-aa8d-9e80e42e419c 61 fields · synced May 16, 2026
- EUDAMED f83b5147-6742-47f2-b34a-515d7db6204c 61 fields · synced May 16, 2026
- EUDAMED 1ea7bead-2edd-477a-b7a6-8da08222a846 61 fields · synced May 16, 2026
- EUDAMED cfc085af-205e-48b3-9409-e12286e614a0 61 fields · synced May 17, 2026
- EUDAMED a76565c5-7829-49ea-a213-f3e9250bfc53 61 fields · synced May 17, 2026
- EUDAMED c1bb1532-135e-4289-9a83-84f6832ab68f 61 fields · synced May 17, 2026
- EUDAMED 60d544d7-454f-4498-9c54-47baef4ffef1 61 fields · synced May 17, 2026
- EUDAMED c6c11056-577d-4502-a132-488c4b9a1c99 61 fields · synced May 18, 2026
- EUDAMED 12e7f1ec-b647-4c1f-af0f-a59567722a2f 61 fields · synced May 18, 2026
- EUDAMED 88573222-3b96-46c6-90ad-a428dc40dfe0 61 fields · synced May 18, 2026
- EUDAMED 60053cbc-ab57-4d3a-9326-f787c116fef8 61 fields · synced Aug 5, 2026