Identity
- Trade Name
- RHINOSCOPES EUDAMEDNA FDA UDI
- Generic Name
- Rigid optical nasopharyngoscope FDA UDI
- Device Name
- Sinuscope EUDAMEDSINUSCOPE 4 MM 0° WL 185 MM, AUTOCLAVABLE FDA UDI
- Model / Reference
- 8300038576 EUDAMEDFDA UDI
- Description
- SINUSCOPE 4 MM 0° WL 185 MM, AUTOCLAVABLE FDA UDI
Identifiers
- Catalog Number
- 8300038576 FDA UDI
- Primary DI / UDI-DI
- 04035873055594 EUDAMEDFDA UDI
- Basic UDI-DI
- 403587312010109A8 EUDAMED
- Direct Marketing DI
- 04035873055594 EUDAMED
- FDA Product Code
- EOB FDA UDI
- EMDN Code
- Z12021008 RHINOSCOPES EUDAMED
- GMDN Term
- Rigid optical nasopharyngoscope FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 874.4760 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 4 Millimeter FDA UDI
Rhinoscopes by Henke-Sass, Wolf GmbH — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 403587312010109A8 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Henke-Sass, Wolf GmbH
- EUDAMED SRN
- DE-MF-000005531
Sources (2)
- EUDAMED cf5f6df5-00c1-4151-9a96-891f53cd3d2e 61 fields · synced Jul 9, 2026
- FDA UDI b135097d-d1e0-4491-9e86-42a64452b8df 35 fields · synced May 30, 2026