Identity
- Trade Name
- Stylet EUDAMED
- Device Name
- Stylet EUDAMED
- Model / Reference
- Insight ST1 EUDAMED13-833 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970831727527 EUDAMED
- Basic UDI-DI
- 697083172ST1SL EUDAMED
- EMDN Code
- R018004 INTUBATION DEVICE GUIDES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Stylet by Shenzhen Insighters Medical Technology Co., Ltd. — 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 | 697083172ST1SL | Class I | Active |
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Manufacturer
- Manufacturer
- Shenzhen Insighters Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000032018
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 49d62799-86de-4a9a-8d3e-7db8b05e411d 61 fields · synced Jul 14, 2026