Identity
- Trade Name
- HYDROVEN EUDAMEDFDA UDI
- Generic Name
- Multi-chamber venous compression system garment, reusable FDA UDI
- Device Name
- ACS900 PUMP UK STD TUBE SET EUDAMEDLEG ASSY CONSOLE 71CM HYDROVEN FDA UDI
- Model / Reference
- 526000-03 EUDAMED5103L71 EUDAMEDFDA UDI
- Description
- LEG ASSY CONSOLE 71CM HYDROVEN FDA UDI
Identifiers
- Catalog Number
- 5103L71 FDA UDI
- Primary DI / UDI-DI
- 05051968031280 EUDAMEDFDA UDI
- Basic UDI-DI
- 5060693520013VG EUDAMED
- FDA Product Code
- JOW FDA UDI
- EMDN Code
- Z120607 PNEUMATIC COMPRESSION EQUIPMENT EUDAMED
- GMDN Term
- Multi-chamber venous compression system garment, reusable 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
Hydroven 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 d84ac4fd-c019-414a-86c1-688efda8a8b5 61 fields · synced Sep 18, 2026
- FDA UDI 4c8bcc78-30c6-4e03-ba0b-86f9509b8adf 36 fields · synced May 30, 2026