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Video laryngoscope
EUDAMEDClass IIa (EU MDR)
Ref /Model insight iS3Ref 17-237Model insight iS3-L; insight iS2; insight iS6; Video Laryngoscope Accessories (Host ;The blade handle; Power Adapter; Micro-USB cable)
Identity
- Trade Name
- Video laryngoscope EUDAMED
- Device Name
- Video Laryngoscope EUDAMED
- Model / Reference
- insight iS3 EUDAMED/ EUDAMEDinsight iS3-L; insight iS2; insight iS6; Video Laryngoscope Accessories (Host ;The blade handle; Power Adapter; Micro-USB cable) EUDAMED17-237 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970831723031 EUDAMED06970831727497 EUDAMED
- Basic UDI-DI
- B-06970831723031 EUDAMED697083172iS3ARB EUDAMED
- Direct Marketing DI
- 06970831727497 EUDAMED
- EMDN Code
- L160202 LARYNGEAL MIRRORS AND HANDLES, REUSABLE EUDAMEDR010280 LARYNGEAL MASKS AND TUBES - ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass I EUDAMED
- Market of Registration
- Italy EUDAMEDGermany 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
Video laryngoscope by Shenzhen Insighters Medical Technology Co., Ltd. — Class IIa — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-06970831723031 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-06970831723031 | Class IIa | 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 (2)
- EUDAMED d82a9aee-efc4-4bce-9a32-317661e2d1cf 61 fields · synced Jul 22, 2026
- EUDAMED 2d5e6347-c765-428f-a368-b1a91062eeed 61 fields · synced May 18, 2026