Identity
- Trade Name
- DVT-4000S FDA UDI
- Generic Name
- Sequential venous compression system inflator FDA UDI
- Device Name
- Main device 1ea, Tubing (2.3m) 2ea [One set box] FDA UDI
- Model / Reference
- DVT-4000S EUDAMEDDS0120 EUDAMEDFDA UDI
- Description
- Main device 1ea, Tubing (2.3m) 2ea [One set box] FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809315675642 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08809315675642 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
Ds0120 by Daesung Maref Co., Ltd. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08809315675642 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Daesung Maref Co., Ltd.
- EUDAMED SRN
- KR-MF-000008616
- Authorised Representative
- KTR Europe GmbH DE-AR-000005685
Sources (2)
- EUDAMED 6a04cf13-de19-4fb6-8847-4bea84565d2d 61 fields · synced Jun 19, 2026
- FDA UDI 4e88be62-92da-40ef-9997-af9415624156 34 fields · synced May 29, 2026