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Krys
EUDAMEDClass I (EU MDR)
Ref 293453Model Hearing instrument chargerRef 293519Ref 293456Ref 293522
Identity
- Trade Name
- Krys EUDAMED
- Model / Reference
- Hearing instrument charger EUDAMED293453 EUDAMED293519 EUDAMED293456 EUDAMED293522 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05714464194360 EUDAMED05714464194384 EUDAMED05714464194377 EUDAMED05714464194391 EUDAMED
- Basic UDI-DI
- 57144640-HICHAR-00094-XK EUDAMED
- EMDN Code
- Y214580 HEARING AIDS OR HEARING DEVICES - ACCESSORIES 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
Krys by Sbo Hearing A/S — 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 | 57144640-HICHAR-00094-XK | Class I | Active |
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Manufacturer
- Manufacturer
- SBO Hearing A/S
- EUDAMED SRN
- DK-MF-000001270
Sources (4)
- EUDAMED 03ab1088-bce7-4868-9c25-a061afddd6f1 61 fields · synced Aug 4, 2026
- EUDAMED 2ba867dc-2331-4fc3-8043-f9098bd30f3f 61 fields · synced May 17, 2026
- EUDAMED b4dcc14b-37d5-456f-a313-924b587cc36a 61 fields · synced May 18, 2026
- EUDAMED c98aa50f-9b2e-4ab3-8c99-d6cc4906f067 61 fields · synced May 18, 2026