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Compression Therapy Device
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref NAModel LGT-2200DVT, LGT-2201DVT, LGT-2200SP, LGT-2200WM/WML, LGT-2200L/LGT-2200LL, LGT-2200DS510(k) K191856
Identity
- Trade Name
- Compression Therapy Device EUDAMED
- Device Name
- Compression Therapy Device EUDAMED
- Model / Reference
- LGT-2200DVT, LGT-2201DVT, LGT-2200SP, LGT-2200WM/WML, LGT-2200L/LGT-2200LL, LGT-2200DS EUDAMEDNA EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-CNMF0000138282200PC EUDAMED
- Basic UDI-DI
- B-CNMF0000138282200PC EUDAMED
- EMDN Code
- Z120607 PNEUMATIC COMPRESSION EQUIPMENT EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMED
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
Compression Therapy Device by Guangzhou Longest Science & Technology Co., Ltd. — Class IIa — FDA_510K, MDD — listed in EUDAMED, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K191856 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-CNMF0000138282200PC | Class IIa | Active |
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Manufacturer
- Manufacturer
- Guangzhou Longest Science & Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000013828
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (3)
- EUDAMED e5716b4c-e7ef-450e-8535-2fe82cac9e91 85 fields · synced Jul 30, 2026
- EUDAMED e5716b4c-e7ef-450e-8535-2fe82cac9e91-1 61 fields · synced Jul 30, 2026
- FDA 510(k) K191856 1 fields · synced May 18, 2026