Identity
- Trade Name
- NA FDA UDI
- Generic Name
- Flexible intubation laryngoscope, video, reusable FDA UDI
- Device Name
- Videoscope EUDAMEDVideoscope is a assistive device designed to operate in comination with Magill Medical's Disposable Video Laryngeal Mask to allow visualization during the processes of laryngeal mask insertion and post-insertion inspection and observation. This model is compatible with Magill Medical's #2 and #2.5 laryngeal masks. FDA UDI
- Model / Reference
- A8, B8 EUDAMEDA2510015 EUDAMEDB8 FDA UDI
- Description
- Videoscope is a assistive device designed to operate in comination with Magill Medical's Disposable Video Laryngeal Mask to allow visualization during the processes of laryngeal mask insertion and post-insertion inspection and observation. This model is compatible with Magill Medical's #2 and #2.5 laryngeal masks. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06974599110546 EUDAMEDFDA UDI
- Basic UDI-DI
- 697459911Videoscope2FU EUDAMED
- Direct Marketing DI
- 06974599110546 EUDAMED
- FDA Product Code
- CAL FDA UDI
- EMDN Code
- Z12021004 VIDEO LARYNGOSCOPES EUDAMED
- GMDN Term
- Flexible intubation laryngoscope, video, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 868.5530 FDA UDI
- Market of Registration
- Portugal EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Videoscope by Changsha Magill Medical Technology Co., Ltd. — Class I — 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 | 697459911Videoscope2FU | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Changsha Magill Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000012007
- Authorised Representative
- Share info GmbH DE-AR-000005132
Sources (2)
- EUDAMED 66116b6b-8453-43e2-a76f-c10d9251f64e 61 fields · synced Jul 9, 2026
- FDA UDI 99f36d51-f9ea-4b36-ac81-8dedfaf6d298 33 fields · synced May 29, 2026