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Single-Use Laryngoscope Blade
EUDAMEDClass I (EU MDR)
Ref iSSULB3MAC4Model SS, S, M, L, i6-SS, i6-S, i6-M, i6-LRef iSSULB6MRef iSSULB6LRef iSSULB3MRef iSSULB6SRef iSSULB3S
Identity
- Trade Name
- Single-Use Laryngoscope Blade EUDAMED
- Device Name
- Single-Use Laryngoscope Blade EUDAMED
- Model / Reference
- SS, S, M, L, i6-SS, i6-S, i6-M, i6-L EUDAMEDiSSULB3MAC4 EUDAMEDiSSULB6M EUDAMEDiSSULB6L EUDAMEDiSSULB3M EUDAMEDiSSULB6S EUDAMEDiSSULB3S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977800301948 EUDAMED06977800301979 EUDAMED06977800301986 EUDAMED06977800301917 EUDAMED06977800301962 EUDAMED06977800301900 EUDAMED
- Basic UDI-DI
- 69708317201037W EUDAMED
- Direct Marketing DI
- 06977800301948 EUDAMED06977800301979 EUDAMED06977800301986 EUDAMED06977800301917 EUDAMED06977800301962 EUDAMED06977800301900 EUDAMED
- EMDN Code
- R9002 LARYNGOSCOPE BLADES, SINGLE-USE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Estonia EUDAMEDItaly EUDAMED
Clinical & Handling
Sterile
Yes
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
Single-Use Laryngoscope Blade 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 | 69708317201037W | 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 (6)
- EUDAMED 985d419d-7a21-4239-9458-ac7011b3774b 61 fields · synced Sep 30, 2026
- EUDAMED 53408c6d-f6ad-4738-9343-d56781b121a8 61 fields · synced May 17, 2026
- EUDAMED 32fb94dc-e743-4e6e-af14-47e27577ceae 61 fields · synced May 18, 2026
- EUDAMED 48ec2473-074c-4804-9065-5d58a1abdacd 61 fields · synced May 18, 2026
- EUDAMED 2823cb98-f598-4a87-858d-0058165a6706 61 fields · synced May 18, 2026
- EUDAMED d3dd54fa-3bf8-4514-827c-29a476631f10 61 fields · synced May 19, 2026