Identity
- Trade Name
- One EUDAMED
- Device Name
- One EUDAMED
- Model / Reference
- 80000120 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850011150221 EUDAMED
- Basic UDI-DI
- 085001115080000120JA EUDAMED
- Direct Marketing DI
- 00850011150221 EUDAMED
- EMDN Code
- Y21450603 BOX HEARING AIDS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Denmark 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
One by AbleNet 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 | 085001115080000120JA | Class I | Active |
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Manufacturer
- Manufacturer
- AbleNet Inc.
- EUDAMED SRN
- US-MF-000008722
- Authorised Representative
- EUCEREP B.V. NL-AR-000001966
Sources (1)
- EUDAMED 88a626eb-188a-4757-99b0-f2785397dde5 61 fields · synced Oct 6, 2026