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Microaire
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 201-02-00Ref 201-00-37Ref 201-03-00
Identity
- Trade Name
- MICROAIRE EUDAMEDMICROAIRE® FDA UDI
- Generic Name
- Disposable surgical irrigation/aspiration system FDA UDI
- Device Name
- Disposable Pulse Lavage EUDAMEDDisposable Lavage Tips EUDAMEDDisposable Pulse Lavage Knee Kit FDA UDI
- Model / Reference
- 201-02-00 EUDAMED201-00-37 EUDAMED201-03-00 EUDAMEDFDA UDI
- Description
- Disposable Pulse Lavage Knee Kit FDA UDI
Identifiers
- Primary DI / UDI-DI
- 16972130470125 EUDAMED16972130470163 EUDAMED16972130470132 EUDAMEDFDA UDI
- Basic UDI-DI
- B-16972130470125 EUDAMEDB-16972130470163 EUDAMEDB-16972130470132 EUDAMED
- FDA Product Code
- FQH FDA UDI
- EMDN Code
- A03040299 IRRIGATION KITS, SINGLE-USE - OTHER EUDAMEDA0380 TUBULAR DEVICES - ACCESSORIES EUDAMED
- GMDN Term
- Disposable surgical irrigation/aspiration system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 880.5475 FDA UDI
- Market of Registration
- Poland 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Introducing the MICROAIRE, a cutting-edge disposable pulse lavage device designed for safe and effective fluid removal. Our FDA-cleared solution has been rigorously tested to ensure sterility and reliability in high-pressure environments.
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-16972130470125 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Apex (Suzhou) Medical Products Company
- EUDAMED SRN
- CN-MF-000031975
- Authorised Representative
- Wellkang Ltd XI-AR-000001836
Sources (4)
- EUDAMED 31ca1592-a4e6-43fb-8587-bc7f4a34fbc4 61 fields · synced Oct 6, 2026
- EUDAMED 04226c87-2182-4ece-b9a8-a67452acb856 61 fields · synced May 18, 2026
- EUDAMED 25ccef2f-658d-4d59-b4e7-ae70f87b3d00 61 fields · synced May 18, 2026
- FDA UDI 398e1b2d-06fc-464d-8e38-0766c95a69ef 33 fields · synced May 30, 2026