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Sinuscope
EUDAMEDClass I (EU MDR)
Ref J1200Model BD-1Ref J0245GRef J0200ERef J0270GRef J0245ERef J0290ERef J0200GRef J02110CRef J2270Ref J2200Ref J0200CG
Identity
- Device Name
- Sinuscope EUDAMED
- Model / Reference
- BD-1 EUDAMEDJ1200 EUDAMEDJ0245G EUDAMEDJ0200E EUDAMEDJ0270G EUDAMEDJ0245E EUDAMEDJ0290E EUDAMEDJ0200G EUDAMEDJ02110C EUDAMEDJ2270 EUDAMEDJ2200 EUDAMEDJ0200CG EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971244213263 EUDAMED06971244213232 EUDAMED06971244213157 EUDAMED06971244213225 EUDAMED06971244213249 EUDAMED06971244213256 EUDAMED06971244213201 EUDAMED06971244213348 EUDAMED06971244213294 EUDAMED06971244213188 EUDAMED06971244213300 EUDAMED
- Basic UDI-DI
- 697124421BDJ00014K EUDAMED
- EMDN Code
- Z12021008 RHINOSCOPES 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
Sinuscope 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 | 697124421BDJ00014K | 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 (11)
- EUDAMED a247ae81-6407-45c6-ac4f-effa147ebbaf 61 fields · synced Oct 6, 2026
- EUDAMED a32bc3ab-f034-43b2-96e4-47c271808164 61 fields · synced May 16, 2026
- EUDAMED a028e091-74a0-48ee-b9c5-911c759cd9fa 61 fields · synced May 17, 2026
- EUDAMED 4d807693-5e05-46a9-a2a4-a7b12269a89c 61 fields · synced May 17, 2026
- EUDAMED f770890e-6346-4071-a81e-4979437acac2 61 fields · synced May 17, 2026
- EUDAMED e3f7bec2-61a7-412d-a57f-a9b1378caf7c 61 fields · synced May 17, 2026
- EUDAMED eb52ccac-f8bf-4ea4-b144-0d1a2e0abf86 61 fields · synced May 17, 2026
- EUDAMED 8956bbcd-83c4-4776-9c07-827a6e9fb531 61 fields · synced May 17, 2026
- EUDAMED 82ddec32-929d-43ec-a668-a0b2017c5e36 61 fields · synced May 18, 2026
- EUDAMED bceed634-71a6-4b08-b815-f2cc48d0677a 61 fields · synced May 18, 2026
- EUDAMED d59a7128-8fe0-463d-93cc-c3fa8d686408 61 fields · synced May 19, 2026