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Sinoscopes
EUDAMEDClass I (EU MDR)
Ref TH3180Model BDRef T0180Ref TH3183Ref T3183JRef B4120Ref B4140Ref TH0183Ref T0187Ref B4130Ref TH0180
Identity
- Trade Name
- Sinoscopes EUDAMED
- Device Name
- Sinoscopes EUDAMED
- Model / Reference
- BD EUDAMEDTH3180 EUDAMEDT0180 EUDAMEDTH3183 EUDAMEDT3183J EUDAMEDB4120 EUDAMEDB4140 EUDAMEDTH0183 EUDAMEDT0187 EUDAMEDB4130 EUDAMEDTH0180 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06947014613106 EUDAMED06947014611669 EUDAMED06947014613113 EUDAMED06947014602742 EUDAMED06947014606764 EUDAMED06947014606771 EUDAMED06947014615766 EUDAMED06947014624515 EUDAMED06947014606924 EUDAMED06947014606757 EUDAMED06947014623662 EUDAMED
- Basic UDI-DI
- 69470146RJ00039510ST EUDAMED
- Direct Marketing DI
- 06947014613106 EUDAMED06947014613113 EUDAMED
- EMDN Code
- Z12021008 RHINOSCOPES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy EUDAMEDAustria EUDAMEDBelgium 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
Sinoscopes by Hangzhou Hawk Optical Electronic Instruments 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 | 69470146RJ00039510ST | Class I | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000028791
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (12)
- EUDAMED 547ad3e8-ed90-4636-a79d-b8c15c517ecf 61 fields · synced Aug 2, 2026
- EUDAMED 0914711d-2abf-4a11-857f-d9e67efaeb6b 61 fields · synced May 19, 2026
- EUDAMED 2bb3c4b9-2256-452d-a559-d58bf207e467 61 fields · synced May 19, 2026
- EUDAMED 817153fb-9573-4b0c-a715-1d4e07286ddb 61 fields · synced Jul 9, 2026
- EUDAMED 6123bf28-3760-4981-8c10-2c823b36a660 61 fields · synced Jul 12, 2026
- EUDAMED c801035d-4a68-4451-8a68-b3fd668a0edd 61 fields · synced Jul 12, 2026
- EUDAMED 754e72f7-e0f1-4a33-a664-0dd2517ce84b 61 fields · synced Jul 16, 2026
- EUDAMED 079c963e-9940-4cb3-af94-5ffbed7126bc 61 fields · synced Jul 16, 2026
- EUDAMED bdc26467-cdc2-4e6d-af68-01d838c3f984 61 fields · synced Jul 26, 2026
- EUDAMED 4d3b657f-2279-42c3-b360-183ac2411d1a 61 fields · synced Jul 28, 2026
- EUDAMED 3211eb8a-26ef-41f5-9dd2-7b64b68a1555 61 fields · synced Aug 2, 2026
- EUDAMED ff6c5dc4-208c-41f3-8f94-38b3133ec851 61 fields · synced Aug 2, 2026