Identity
- Device Name
- Sinoscopes EUDAMED
- Model / Reference
- BD EUDAMEDB4110 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06947014606788 EUDAMED
- Basic UDI-DI
- 69470146RJ00039510ST EUDAMED
- EMDN Code
- Z12021008 RHINOSCOPES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Belgium 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 (1)
- EUDAMED 6cfc6109-85f7-4165-94b5-d6cfdcf4926f 61 fields · synced Jun 19, 2026