Identity
- Trade Name
- Hansol Medical Co. FDA UDI
- Generic Name
- Cupping therapy device FDA UDI
- Device Name
- Cupping Therapy Device EUDAMED
- Model / Reference
- 19PCS EUDAMEDHANSOL Cupping Set(19PCS) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809118710014 EUDAMEDFDA UDI
- Basic UDI-DI
- 880911871HS0002A8 EUDAMED
- FDA Product Code
- KNM FDA UDI
- EMDN Code
- Z120611 VACUUM THERAPY EQUIPMENT EUDAMED
- GMDN Term
- Cupping therapy device FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.5765 FDA UDI
- Market of Registration
- Germany 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Cupping Therapy Device by Hansol Medical Co. — 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 | 880911871HS0002A8 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Hansol Medical Co.
- EUDAMED SRN
- KR-MF-000023984
- Authorised Representative
- Meridius Medical Europe Limited IE-AR-000004258
Sources (2)
- EUDAMED c0c6fc21-70ba-484d-95d0-330d515ad5c8 61 fields · synced Jun 19, 2026
- FDA UDI cce6becf-d228-4ea3-ae6d-8b7146eaedc0 32 fields · synced May 30, 2026