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Electronic Nasopharyngeal Endoscope
EUDAMEDClass I (EU MDR)
Ref iS-ENF22Model iS-ENF22, iS-ENC32, iS-ENC42, iS-ENF32, iS-ENF42Ref iS-ENF32Ref iS-ENF42
Identity
- Trade Name
- Electronic Nasopharyngeal Endoscope EUDAMED
- Device Name
- Electronic Nasopharyngeal Endoscope EUDAMED
- Model / Reference
- iS-ENF22, iS-ENC32, iS-ENC42, iS-ENF32, iS-ENF42 EUDAMEDiS-ENF22 EUDAMEDiS-ENF32 EUDAMEDiS-ENF42 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977800302808 EUDAMED06977800302013 EUDAMED06977800302020 EUDAMED
- Basic UDI-DI
- 697083172ENZK EUDAMED
- Direct Marketing DI
- 06977800302808 EUDAMED06977800302013 EUDAMED06977800302020 EUDAMED
- EMDN Code
- R010101 NASOPHARYNGEAL TUBES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Romania EUDAMEDItaly 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
Category: Nasopharyngeal airway, single-use
Electronic Nasopharyngeal Endoscope by Shenzhen Insighters Medical Technology Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Nasopharyngeal airway, single-use.
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- Disposable sterile nasopharyngeal tube — Rmist(Tianjin) Medical Device Co., Ltd. · Class IIa
- Shiley — Covidien LP · Class I
- Disposable sterile nasopharyngeal tube — Rmist(Tianjin) Medical Device Co., Ltd. · Class IIa
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 | 697083172ENZK | 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 (3)
- EUDAMED d0f52281-88b8-438d-9133-723f05759d38 61 fields · synced Jul 26, 2026
- EUDAMED 5fbf3188-bd7d-498a-89a9-0f1f93110c8c 61 fields · synced Jun 18, 2026
- EUDAMED 8b6bcf21-c668-4557-bce3-1d5525e19e90 61 fields · synced Jul 26, 2026