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Sinuscope
EUDAMEDClass I (EU MDR)
Ref 80027.417Model Refer to the IFU.Ref BJ-1Ref 80027.217Ref 80023.317Ref BJ-1GRef 80020.417HDRef 80020.217Ref 80020.417GRef 80024.417Ref 8002A.417Ref 80020.417CGRef 80027.317Ref BJ-1CGRef 80027.417G
Identity
- Trade Name
- Sinuscope EUDAMED
- Device Name
- Sinuscope EUDAMED
- Model / Reference
- Refer to the IFU. EUDAMED80027.417 EUDAMEDBJ-1 EUDAMED80027.217 EUDAMED80023.317 EUDAMEDBJ-1G EUDAMED80020.417HD EUDAMED80020.217 EUDAMED80020.417G EUDAMED80024.417 EUDAMED8002A.417 EUDAMED80020.417CG EUDAMED80027.317 EUDAMEDBJ-1CG EUDAMED80027.417G EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976042831138 EUDAMED06976042831343 EUDAMED06976042831336 EUDAMED06976042831299 EUDAMED06976042831350 EUDAMED06976042831251 EUDAMED06976042831312 EUDAMED06976042831183 EUDAMED06976042831152 EUDAMED06976042831176 EUDAMED06976042831220 EUDAMED06976042831305 EUDAMED06976042831367 EUDAMED06976042831213 EUDAMED
- Basic UDI-DI
- 697604283SZ-BJP2 EUDAMED
- EMDN Code
- Z12021008 RHINOSCOPES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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 Jiangxi China Medical Equipment 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 | 697604283SZ-BJP2 | Class I | Active |
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Manufacturer
- Manufacturer
- Jiangxi China Medical Equipment Co., Ltd
- EUDAMED SRN
- CN-MF-000037457
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (14)
- EUDAMED eb17767e-22fc-460e-b571-e04bb1a5abd0 61 fields · synced Aug 3, 2026
- EUDAMED 3223f3ab-8830-41fc-9da4-28174899d77b 61 fields · synced May 16, 2026
- EUDAMED 9529e547-5c10-4c42-a37b-d6d8f4a74317 61 fields · synced May 17, 2026
- EUDAMED 78eba3a3-8bda-4637-8ab2-96b203b8055e 61 fields · synced May 17, 2026
- EUDAMED eaa15624-79ea-4613-8094-edbada13a28e 61 fields · synced May 17, 2026
- EUDAMED ad66ac5c-80c1-4f9b-bc43-3edf2db0efc3 61 fields · synced May 17, 2026
- EUDAMED 50ae85e0-c288-4aa4-9fe4-90e91b136a82 61 fields · synced May 18, 2026
- EUDAMED 73352c71-d371-4b1c-a417-eb17c4c69507 61 fields · synced May 18, 2026
- EUDAMED 24ab6415-67f8-486f-a99e-9aad2e014ede 61 fields · synced May 18, 2026
- EUDAMED a75bbfdc-0d43-4b7f-a3e4-bf2d88f26663 61 fields · synced May 18, 2026
- EUDAMED 8c99b247-29d7-4498-9ca8-7e234f593b38 61 fields · synced May 18, 2026
- EUDAMED e2f31b4f-55a8-47e0-8501-17a9a73484ca 61 fields · synced May 18, 2026
- EUDAMED ca7c0624-d13b-4f16-b968-2f4f714a6277 61 fields · synced May 19, 2026
- EUDAMED 2b89d719-21a6-4089-baeb-14300544b0d2 61 fields · synced May 19, 2026