Identity
- Trade Name
- WOUNDEXPRESS EUDAMEDFDA UDI
- Generic Name
- Multi-chamber venous compression system garment, single-use FDA UDI
- Device Name
- ACS900 PUMP UK STD TUBE SET EUDAMEDWOUNDEXPRESS IPC GARMENT : SIZE RANGE 43 - 77CM (17 - 28 INCHES) FDA UDI
- Model / Reference
- 526000-03 EUDAMEDWE100G EUDAMEDFDA UDI
- Description
- WOUNDEXPRESS IPC GARMENT : SIZE RANGE 43 - 77CM (17 - 28 INCHES) FDA UDI
Identifiers
- Catalog Number
- WE100G FDA UDI
- Primary DI / UDI-DI
- 05051968040374 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, single-use 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
Dimensions & Sizes
- Size
- Outer Diameter — 77 Centimeter FDA UDIOuter Diameter — 28 Inch FDA UDI
Woundexpress 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 8bdd1485-624d-48f9-bc3d-51bdecb2ef3b 61 fields · synced Jul 22, 2026
- FDA UDI 279b3bf8-46b2-4f4a-ab9f-07a204c6893a 37 fields · synced May 30, 2026