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Electronic Nasopharyngolaryngoscope
EUDAMEDClass I (EU MDR)
Ref DBJ-2Model DBJ-1
Identity
- Device Name
- Electronic Nasopharyngolaryngoscope EUDAMED
- Model / Reference
- DBJ-1 EUDAMEDDBJ-2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971244215014 EUDAMED06971244215007 EUDAMED
- Basic UDI-DI
- 697124421DB0001WK EUDAMED
- EMDN Code
- Z12021006 VIDEO NASOPHARYNGO/LARYNGOSCOPES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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
Electronic Nasopharyngolaryngoscope by Shenyang Shenda Endoscope 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 | 697124421DB0001WK | Class I | Active |
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Manufacturer
- Manufacturer
- Shenyang Shenda Endoscope Co., Ltd.
- EUDAMED SRN
- CN-MF-000030478
- Authorised Representative
- Lepu Medical (Europe) Cooperatief U.A. NL-AR-000000551
Sources (2)
- EUDAMED 620291d4-6758-4755-9ac4-92439218c92d 61 fields · synced Jul 8, 2026
- EUDAMED 2e93c3a2-1787-450a-8461-cc5afdb115ef 61 fields · synced May 18, 2026