Identity
- Trade Name
- Flexicouplers EUDAMED
- Device Name
- Flexicoupler and Jelly Tab Combo Pack EUDAMED
- Model / Reference
- 011445 EUDAMED040517 EUDAMED040670 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05713315011702 EUDAMED05713315011986 EUDAMED05713315011993 EUDAMED
- Basic UDI-DI
- 5713315NA001085D EUDAMED
- EMDN Code
- Z129013 GENERAL AUDITORY AND/OR VISUAL STIMULATORS EUDAMEDZ12149005 IMPEDANCE METERS FOR THE AUDITORY SYSTEM 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
Category: Auditory stimulator
Flexicouplers 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 | 5713315NA001085D | Class I | Active |
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Manufacturer
- Manufacturer
- Natus Medical Denmark ApS
- EUDAMED SRN
- DK-MF-000001617
Sources (3)
- EUDAMED 7c4ed9d4-ad7a-4886-996b-5d6c5b7e839b 61 fields · synced Jul 24, 2026
- EUDAMED 5b2c89ae-1ff3-4b7b-a9de-b4b1c1bfab3a 61 fields · synced May 17, 2026
- EUDAMED 85c898c0-e0a0-4a55-9183-b8390faf6e47 61 fields · synced May 18, 2026