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Video Laryngoscope for Tracheal Intubation
EUDAMEDFDA UDIClass I (EU MDR)
Ref UED-A3Model UED-A0, UED-A3, UET-A0, UET-A3
Identity
- Trade Name
- Video Laryngoscope for Tracheal Intubation EUDAMEDUESCOPE Single-Use Laryngoscope Blade, Size A3 FDA UDI
- Generic Name
- Laryngoscope blade, single-use FDA UDI
- Device Name
- Video Laryngoscope for Tracheal Intubation EUDAMED
- Model / Reference
- UED-A0, UED-A3, UET-A0, UET-A3 EUDAMEDUED-A3 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06937048201196 EUDAMED06970283489189 FDA UDI
- Basic UDI-DI
- 697028348EU000008HD EUDAMED
- FDA Product Code
- CCW FDA UDI
- EMDN Code
- Z12021004 VIDEO LARYNGOSCOPES EUDAMED
- GMDN Term
- Laryngoscope blade, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 868.5540 FDA UDI
- Special Device Type
- Software EUDAMED
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Video Laryngoscope for Tracheal Intubation by Zhejiang UE Medical Corp. — 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 | 697028348EU000008HD | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Zhejiang UE Medical Corp.
- EUDAMED SRN
- CN-MF-000003020
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (2)
- EUDAMED 8f925ce0-42b4-4f1e-9d16-656b23dc878e 61 fields · synced Jun 18, 2026
- FDA UDI 55fc88f9-9b0b-4440-9ca0-2938e0680261 33 fields · synced May 30, 2026