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Air Pressure Therapy System
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref VU-IPCU8Model VU-IPCU8
Identity
- Trade Name
- VU FDA UDI
- Generic Name
- Freestanding electric massager FDA UDI
- Device Name
- Air Pressure Therapy System EUDAMEDFDA UDI
- Model / Reference
- VU-IPCU8 EUDAMEDFDA UDI
- Description
- Air Pressure Therapy System FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06971234470300 EUDAMED06971234479419 FDA UDI
- Basic UDI-DI
- 697123447VU-IPCU8BD EUDAMED
- FDA Product Code
- IRP FDA UDI
- EMDN Code
- Z120607 PNEUMATIC COMPRESSION EQUIPMENT EUDAMED
- GMDN Term
- Freestanding electric massager FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 890.5650 FDA UDI
- Market of Registration
- Austria 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
No
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
Air Pressure Therapy System by Xiamen Weiyou Intelligent Technology Co., Ltd — 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 | 697123447VU-IPCU8BD | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Xiamen Weiyou Intelligent Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000028653
- Authorised Representative
- Sungo Cert GmbH DE-AR-000010869
Sources (2)
- EUDAMED 3f133fa5-7af7-4686-b8b0-3e707ace9dca 61 fields · synced Jul 12, 2026
- FDA UDI d0fb0126-7649-47c2-9699-e87a01f06da6 33 fields · synced May 30, 2026