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Main Unit 3.5’’
EUDAMEDClass I (EU MDR)
Ref P9440Model DR-B,DR-BH,DR-C,DR-B,DR-BH,SD-300C
Identity
- Trade Name
- Main Unit 3.5’’ EUDAMED
- Device Name
- Video-Rhinolaryngoscope EUDAMED
- Model / Reference
- DR-B,DR-BH,DR-C,DR-B,DR-BH,SD-300C EUDAMEDP9440 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06947014614141 EUDAMED
- Basic UDI-DI
- 69470146EJ00323010DT EUDAMED
- EMDN Code
- Z12021006 VIDEO NASOPHARYNGO/LARYNGOSCOPES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
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
Main Unit 3.5’’ 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 | 69470146EJ00323010DT | 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 3c213c44-752d-4fc5-b897-e932c6f02f7d 61 fields · synced Jun 19, 2026