← Back to catalogue
Sinuscope
EUDAMEDClass I (EU MDR)
Ref B704ACModel B005AC、B305AC、B004AC、B304AC、B704AC、B003AE、B303AE、B703AE、B003AF、B303AF、B703AFRef B003AERef B004ACRef B305ACRef B003AFRef B303AF
Identity
- Trade Name
- Sinuscope EUDAMED
- Device Name
- Sinuscope EUDAMED
- Model / Reference
- B005AC、B305AC、B004AC、B304AC、B704AC、B003AE、B303AE、B703AE、B003AF、B303AF、B703AF EUDAMEDB704AC EUDAMEDB003AE EUDAMEDB004AC EUDAMEDB305AC EUDAMEDB003AF EUDAMEDB303AF EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975465800240 EUDAMED06975465800257 EUDAMED06975465800226 EUDAMED06975465800219 EUDAMED06975465800288 EUDAMED06975465800295 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Wuzhou Aokace Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000027213
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (6)
- EUDAMED 42ba2b8f-523d-4cf4-b1ce-f8271c48890d 61 fields · synced Jul 26, 2026
- EUDAMED f15b6a75-234b-49ff-b7a1-f5ee0fb2799e 61 fields · synced May 18, 2026
- EUDAMED 0518f032-becc-4782-80e1-854bff60d2d5 61 fields · synced May 18, 2026
- EUDAMED c525a98b-fa00-46d6-a6bb-8b5edd8e6a98 61 fields · synced May 18, 2026
- EUDAMED daa25996-0b6f-4f48-a805-526e108cc443 61 fields · synced May 18, 2026
- EUDAMED 43cb1e9e-74d5-42e9-b495-400c5a348fec 61 fields · synced May 19, 2026