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Dvt4200-3
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref DVT4200-3Model DVT-4000S
Identity
- Trade Name
- DVT-4000S FDA UDI
- Generic Name
- Sequential venous compression system inflator FDA UDI
- Device Name
- Main device 1ea, Tubing(3m) 2ea [One set box] FDA UDI
- Model / Reference
- DVT-4000S EUDAMEDDVT4200-3 EUDAMEDFDA UDI
- Description
- Main device 1ea, Tubing(3m) 2ea [One set box] FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809315675659 EUDAMEDFDA UDI18809315675656 EUDAMED
- Basic UDI-DI
- B-08809315675659 EUDAMEDB-18809315675656 EUDAMED
- 510(k) Number
- K203417 FDA UDI
- FDA Product Code
- JOW FDA UDI
- EMDN Code
- Z120607 PNEUMATIC COMPRESSION EQUIPMENT EUDAMED
- GMDN Term
- Sequential venous compression system inflator FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.5800 FDA UDI
- Market of Registration
- France 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
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
Prescription Use
Yes
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dvt4200-3 by Daesung Maref Co., Ltd. — Class IIa — FDA_510K, MDD — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
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 | K203417 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-08809315675659 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Daesung Maref Co., Ltd.
- EUDAMED SRN
- KR-MF-000008616
- Authorised Representative
- KTR Europe GmbH DE-AR-000005685
Sources (4)
- EUDAMED 62a5b029-20f1-4cb8-b0fe-4577b41ab228 61 fields · synced Jul 12, 2026
- EUDAMED 0aca3687-50d8-498f-978b-bc1bc416da7e 61 fields · synced May 18, 2026
- FDA UDI e8a17427-34ae-4fcf-9f1a-bf2d888c0099 34 fields · synced May 30, 2026
- FDA 510(k) K203417 1 fields · synced May 18, 2026