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Air-Q3 Self Pressurizing ILA with Automatic Cuff Inflation and GA Size 4.0
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 60405Model Air-Q®3 Supraglottic Airway Mask (SGA)
by SunMed
Identity
- Trade Name
- Air-Q3 Self Pressurizing ILA with Automatic Cuff Inflation and GA Size 4.0 EUDAMEDAir-Q3® FDA UDI
- Generic Name
- Laryngeal mask airway, single-use FDA UDI
- Device Name
- Air-Q3 Self Pressurizing ILA with Automatic Cuff Inflation and GA Size 4.0 FDA UDI
- Model / Reference
- Air-Q®3 Supraglottic Airway Mask (SGA) EUDAMED60405 EUDAMEDFDA UDI
- Description
- Air-Q3 Self Pressurizing ILA with Automatic Cuff Inflation and GA Size 4.0 FDA UDI
Identifiers
- Catalog Number
- 60405 FDA UDI
- Primary DI / UDI-DI
- 10889483480700 EUDAMEDFDA UDI
- Basic UDI-DI
- 0889483Air-Q3DF EUDAMED
- FDA Product Code
- CAE FDA UDI
- EMDN Code
- R01020199 LARYNGEAL MASKS - OTHER EUDAMED
- GMDN Term
- Laryngeal mask airway, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 868.5110 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
Yes
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
MR Safe FDA UDI
Air-Q3 Self Pressurizing ILA with Automatic Cuff Inflation and GA Size 4.0 by SunMed — 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 | 0889483Air-Q3DF | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- SunMed
- EUDAMED SRN
- US-MF-000009164
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (2)
- EUDAMED 4bf66d36-f06e-4940-9ac1-98e39355c746 61 fields · synced Aug 2, 2026
- FDA UDI 8d3b6326-3de0-45ab-bac6-d2d3d2476d41 36 fields · synced May 30, 2026