Identity
- Trade Name
- Hansol Medical Co. FDA UDI
- Generic Name
- Cupping therapy device FDA UDI
- Device Name
- Cupping Therapy Device EUDAMED
- Model / Reference
- 17PCS EUDAMEDHANSOL Cupping Set(17PCS) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809118710137 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
Category: Cupping therapy device
Cupping Therapy Device by Hansol Medical Co. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cupping therapy device.
- Fascia Buddy Silicone Cups - Small — Eastern Currents Distributing Ltd · Class I
- LymphaTouch — LymphaTouch Oy · Class IIa
- Vacuum cupping and Tools — TENS PLUS INDUSTRIAL COMPANY · Class I
- Safety Trap — ACARE TECHNOLOGY CO., LTD. · Class I
- GLASS CUP FLAT TOP NO.2 — TENS PLUS INDUSTRIAL COMPANY · Class I
- Tiger Warmer Large — Dong Bang Medical co., Ltd. · Class I
- iCare Vacuum Cupping Set — Prime Holly Corporation · Class I
- Vacuum cupping and Tools — TENS PLUS INDUSTRIAL COMPANY · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Hansol Medical Co.
- EUDAMED SRN
- KR-MF-000023984
- Authorised Representative
- Meridius Medical Europe Limited IE-AR-000004258
Sources (2)
- EUDAMED 27db2a66-b708-4d82-b29d-3ad682a226d8 61 fields · synced Jul 25, 2026
- FDA UDI 4a6d2218-d07e-4fd8-bafd-7b43f2feb70c 32 fields · synced May 30, 2026