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Video Flexible Nasopharyngo Laryngoscope ENT-30VE
EUDAMEDFDA UDIClass I (EU MDR)
Ref ENT-30VE
Identity
- Trade Name
- Video Flexible Nasopharyngo Laryngoscope ENT-30VE EUDAMEDMACHIDA FDA UDI
- Generic Name
- Flexible video nasopharyngoscope FDA UDI
- Device Name
- Video Flexible Nasopharyngo Laryngoscope EUDAMED
- Model / Reference
- ENT-30VE EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04580137733034 EUDAMEDFDA UDI
- Basic UDI-DI
- 458013773C0013U EUDAMED
- 510(k) Number
- K821182 FDA UDI
- FDA Product Code
- EQN FDA UDI
- EMDN Code
- Z12021006 VIDEO NASOPHARYNGO/LARYNGOSCOPES EUDAMED
- GMDN Term
- Flexible video nasopharyngoscope FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 874.4760 FDA UDI
- Market of Registration
- Spain 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
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
Yes
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
Yes
FDA UDI
Video Flexible Nasopharyngo Laryngoscope ENT-30VE by Machida Endoscope Co., Ltd. — Class I — 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 | 458013773C0013U | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Machida Endoscope Co., Ltd.
- EUDAMED SRN
- JP-MF-000008990
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 4569441c-f3e4-4661-a962-92e7d7d4e62d 61 fields · synced Oct 7, 2026
- FDA UDI 8f991883-3498-4d17-872f-d24df5484cd1 34 fields · synced May 30, 2026