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Sinuscope
EUDAMEDClass I (EU MDR)
Ref B303AEModel B005AC、B305AC、B004AC、B304AC、B704AC、B003AE、B303AE、B703AE、B003AF、B303AF、B703AF
Identity
- Trade Name
- Sinuscope EUDAMED
- Device Name
- Sinuscope EUDAMED
- Model / Reference
- B005AC、B305AC、B004AC、B304AC、B704AC、B003AE、B303AE、B703AE、B003AF、B303AF、B703AF EUDAMEDB303AE EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975465800264 EUDAMED
- Basic UDI-DI
- 697546580SBAERP EUDAMED
- EMDN Code
- Z12021008 RHINOSCOPES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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 Wuzhou Aokace 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 | 697546580SBAERP | Class I | Active |
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Manufacturer
- Manufacturer
- Wuzhou Aokace Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000027213
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 2df83fc6-28b9-457b-8c1f-7175b8b19171 61 fields · synced Jun 17, 2026