Identity
- Trade Name
- LYMPHASSIST EUDAMEDHYDROVEN FDA UDI
- Generic Name
- Sequential venous compression system FDA UDI
- Device Name
- ACS900 PUMP UK STD TUBE SET EUDAMEDHYDROVEN 12 LYMPHASSIST HC PUMP FDA UDI
- Model / Reference
- 526000-03 EUDAMED316EURHC EUDAMEDFDA UDI
- Description
- HYDROVEN 12 LYMPHASSIST HC PUMP FDA UDI
Identifiers
- Catalog Number
- LYMPHASSIST/HC FDA UDI
- Primary DI / UDI-DI
- 05051968032874 EUDAMEDFDA UDI
- Basic UDI-DI
- 5060693520013VG EUDAMED
- FDA Product Code
- JOW FDA UDI
- EMDN Code
- Z120607 PNEUMATIC COMPRESSION EQUIPMENT EUDAMED
- GMDN Term
- Sequential venous compression system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.5800 FDA UDI
- Market of Registration
- Ireland 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
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
Lymphassist by Arjohuntleigh AB — Class IIa — 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 | 5060693520013VG | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- ArjoHuntleigh AB
- EUDAMED SRN
- SE-MF-000000696
Sources (2)
- EUDAMED bef1349e-f8c1-440b-bf88-a2ccef4c5e8a 61 fields · synced Jun 19, 2026
- FDA UDI 1cf9070f-a96c-432c-a6aa-015d7f35a6d8 36 fields · synced May 30, 2026