Identity
- Trade Name
- Karman Line TEMPO EUDAMED
- Device Name
- Karman Line EUDAMED
- Model / Reference
- 01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08720892379818 EUDAMED
- Basic UDI-DI
- 8720892379801AF EUDAMED
- Direct Marketing DI
- 08720892379818 EUDAMED
- EMDN Code
- Z12101106 NEUROLOGICAL STIMULATORS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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
Karman Line TEMPO by Stichting Yellow Riders — 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 | 8720892379801AF | Class I | Active |
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Manufacturer
- Manufacturer
- Stichting Yellow Riders
- EUDAMED SRN
- NL-MF-000039422
Sources (1)
- EUDAMED aa91dd8b-0f16-4028-bf57-57899cc129bf 61 fields · synced Jun 18, 2026