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Echo SCreen III Accessories
EUDAMEDClass I (EU MDR)
Ref 009149Model 011010Ref 012625Ref 010999Ref 013570
Identity
- Trade Name
- Echo SCreen III Accessories EUDAMED
- Device Name
- ECHO-SCREEN III DOCKING STATION EUDAMED
- Model / Reference
- 011010 EUDAMED009149 EUDAMED012625 EUDAMED010999 EUDAMED013570 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05713315012013 EUDAMED05713315012051 EUDAMED05713315012037 EUDAMED05713315012044 EUDAMED05713315012068 EUDAMED
- Basic UDI-DI
- 5713315NA001415B EUDAMED
- EMDN Code
- Z129013 GENERAL AUDITORY AND/OR VISUAL STIMULATORS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Denmark EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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: Auditory stimulator
Echo SCreen III Accessories by Natus Medical Denmark ApS — 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 | 5713315NA001415B | Class I | Active |
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Manufacturer
- Manufacturer
- Natus Medical Denmark ApS
- EUDAMED SRN
- DK-MF-000001617
Sources (5)
- EUDAMED f592b03d-54f6-474d-937d-df32eb564e63 61 fields · synced Jul 29, 2026
- EUDAMED a6f95f16-36ac-45d9-b796-1d7890220cd1 61 fields · synced May 17, 2026
- EUDAMED bdb15403-6404-4c9a-aa19-f8cf468108cd 61 fields · synced May 18, 2026
- EUDAMED 12363a07-64f0-47f0-b6ff-6e62d7a2db7e 61 fields · synced May 19, 2026
- EUDAMED 92f2d482-d086-4066-8606-c7233352d845 61 fields · synced May 19, 2026