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Single-Use Laryngoscope Blade
EUDAMEDClass I (EU MDR)
Ref iSSULB3MAC3Model SS, S, M, L, i6-SS, i6-S, i6-M, i6-L
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 EUDAMEDiSSULB3MAC3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977800301931 EUDAMED
- Basic UDI-DI
- 69708317201037W EUDAMED
- Direct Marketing DI
- 06977800301931 EUDAMED
- EMDN Code
- R9002 LARYNGOSCOPE BLADES, SINGLE-USE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Estonia 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 (1)
- EUDAMED 808e6e2d-1726-48c2-8590-f5e83f431c23 61 fields · synced Jun 19, 2026