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Single-use RhinoLaryngoscope
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref RH-M58HModel RH-M58,RH-M52,RH-M50,RH-M40,RH-M32,RH-M22,RH-M58H,RH-M52H,RH-M40H
Identity
- Trade Name
- Single-Use Rhinolaryngoscope FDA UDI
- Generic Name
- Flexible video otorhinolaryngoscope, single-use FDA UDI
- Device Name
- Single-use RhinoLaryngoscope EUDAMED
- Model / Reference
- RH-M58,RH-M52,RH-M50,RH-M40,RH-M32,RH-M22,RH-M58H,RH-M52H,RH-M40H EUDAMEDRH-M58H EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06970462541431 EUDAMED06970462546429 FDA UDI
- Basic UDI-DI
- 69704625420187W EUDAMED
- 510(k) Number
- K232435 FDA UDI
- FDA Product Code
- EOB FDA UDI
- EMDN Code
- Z12021003,Z12021008 EUDAMED
- GMDN Term
- Flexible video otorhinolaryngoscope, single-use 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
Yes
EUDAMEDFDA UDI
Single Use
Yes
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
No
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Single-use RhinoLaryngoscope by Shenzhen HugeMed Medical Technical Development Co., Ltd. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 69704625420187W | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- EUDAMED SRN
- CN-MF-000010895
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED b3f0c400-2bd0-4d9f-894e-e2764725c943 61 fields · synced Jul 10, 2026
- FDA UDI 1ba1684e-e7fd-4159-a81d-7225c140c99f 33 fields · synced May 29, 2026