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Sequential Compression System
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref SCD600Ref SCD600
Identity
- Trade Name
- Sequential Compression System EUDAMED
- Device Name
- Sequential Compression System EUDAMED
- Model / Reference
- SCD600 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06945429021226 EUDAMED
- Basic UDI-DI
- 69454290SC001N5 EUDAMEDB-06945429021226 EUDAMED
- Direct Marketing DI
- 06945429021226 EUDAMED
- EMDN Code
- C01050299 INTRAVASCULAR EMBOLIC PROTECTION CATHETERS AND SYSTEMS - OTHER EUDAMEDM030405 COMPRESSION STOCKINGS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Sequential Compression System by Shenzhen Comen Medical Instruments Co., LTD. — Class IIa — FDA_510K, MDD, MDR — listed in EUDAMED, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K250190 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | 69454290SC001N5 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 69454290SC001N5 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shenzhen Comen Medical Instruments Co., LTD.
- EUDAMED SRN
- CN-MF-000002236
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (3)
- EUDAMED 7ab2dc40-da54-468e-b17f-a5c95bcd5b9d 61 fields · synced Oct 6, 2026
- EUDAMED c7b97ce8-7b14-432a-958d-044a2be2ac49 61 fields · synced May 19, 2026
- FDA 510(k) K250190 1 fields · synced May 18, 2026