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Ds302
EUDAMEDFDA UDIClass I (EU MDR)
Ref DS302Model Applicable to devices under Basic UDI-DI: 880931567DVTSD
Identity
- Trade Name
- DVT-SERIES FDA UDI
- Generic Name
- Multi-chamber venous compression system garment, reusable FDA UDI
- Device Name
- Tubing (Single hose 1.5m) 2ea [One polybag] FDA UDI
- Model / Reference
- Applicable to devices under Basic UDI-DI: 880931567DVTSD EUDAMEDDS302 EUDAMEDFDA UDI
- Description
- Tubing (Single hose 1.5m) 2ea [One polybag] FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809315675338 EUDAMEDFDA UDI
- Basic UDI-DI
- 880931567DVTSLEEVEAL EUDAMED
- FDA Product Code
- JOW FDA UDI
- EMDN Code
- Z12069080 VARIOUS PHYSIOTHERAPY AND REHABILITATION INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Multi-chamber venous compression system garment, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 870.5800 FDA UDI
- Market of Registration
- Italy 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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Ds302 by Daesung Maref Co., Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 880931567DVTSLEEVEAL | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Daesung Maref Co., Ltd.
- EUDAMED SRN
- KR-MF-000008616
- Authorised Representative
- KTR Europe GmbH DE-AR-000005685
Sources (2)
- EUDAMED 2f33cece-9507-4a12-82aa-dd1d3dace508 61 fields · synced Jun 18, 2026
- FDA UDI 9c130abe-76a5-4296-baa9-5bcc7ee35796 34 fields · synced May 30, 2026