Identity
- Trade Name
- VU FDA UDI
- Generic Name
- Freestanding electric massager FDA UDI
- Device Name
- Hand Rehabilitation Device EUDAMEDhand rehabilitation robot FDA UDI
- Model / Reference
- SL-FR01 EUDAMEDFDA UDI
- Description
- hand rehabilitation robot FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06971234470485 EUDAMED06971234479570 FDA UDI
- Basic UDI-DI
- 697123447SL-FR01LZ EUDAMED
- FDA Product Code
- ISA FDA UDI
- EMDN Code
- Y0503 HANDS AND FINGERS RE-EDUCATION DEVICES EUDAMED
- GMDN Term
- Freestanding electric massager FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.5660 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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Hand Rehabilitation Device by Xiamen Weiyou Intelligent Technology Co., Ltd — Class I — 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 | 697123447SL-FR01LZ | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | 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 0f902aeb-68ec-4898-b8a2-ab2c7e131c3e 61 fields · synced Jul 9, 2026
- FDA UDI 9a713fc5-76e6-4d99-a712-a4957f551817 33 fields · synced May 30, 2026