Identity
- Trade Name
- Jelly Tab Sensor EUDAMED
- Device Name
- Flexicoupler and Jelly Tab Combo Pack EUDAMED
- Model / Reference
- 011445 EUDAMED040587 EUDAMED040532 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05713315011733 EUDAMED05713315011979 EUDAMED
- Basic UDI-DI
- 5713315NA001085D 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
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
Jelly Tab Sensor 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 (2)
- EUDAMED 805151b6-0ba5-4c1a-87d3-0ae3ae248449 61 fields · synced Aug 2, 2026
- EUDAMED 1c8aa4ca-5416-40a5-9c5b-95e8469ed31c 61 fields · synced May 18, 2026