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Hydroven
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 316JIFModel 526000-03Ref 316001Ref 316LI76Ref 510004Ref 316JA68Ref 316EURRef 316JIS78Ref 316JA78Ref 316BR78Ref 316BL78Ref 316J78Ref 510001Ref 510EURRef 510004EERef 510004HDERef 316004DE
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 EUDAMED76CM LEG INSERT FDA UDI
- Model / Reference
- 526000-03 EUDAMED316JIF EUDAMED316001 EUDAMED316LI76 EUDAMEDFDA UDI510004 EUDAMED316JA68 EUDAMED316EUR EUDAMED316JIS78 EUDAMED316JA78 EUDAMED316BR78 EUDAMED316BL78 EUDAMED316J78 EUDAMED510001 EUDAMED510EUR EUDAMED510004EE EUDAMED510004HDE EUDAMED316004DE EUDAMED
- Description
- 76CM LEG INSERT FDA UDI
Identifiers
- Catalog Number
- 316LI76 FDA UDI
- Primary DI / UDI-DI
- 05051968043948 EUDAMED05051968031808 EUDAMED05051968031501 EUDAMEDFDA UDI05051968031921 EUDAMED05051968045164 EUDAMED05051968032331 EUDAMED05051968045027 EUDAMED05051968043962 EUDAMED05051968043993 EUDAMED05051968043986 EUDAMED05051968043924 EUDAMED05051968031891 EUDAMED05051968032348 EUDAMED05051968036674 EUDAMED05051968036667 EUDAMED05051968031822 EUDAMED
- 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 (17)
- EUDAMED be9f99df-d684-4fe1-9cce-a66ebcd32005 61 fields · synced Sep 17, 2026
- EUDAMED 86600d88-34b7-4047-a20b-93145f3651cb 61 fields · synced May 16, 2026
- EUDAMED f1f5cabb-be65-4a8f-a09d-203fd2d5e2c2 61 fields · synced May 16, 2026
- EUDAMED e90d9fb3-9367-4525-94c9-eaf2a0f203ef 61 fields · synced May 16, 2026
- EUDAMED 0e04dc60-5116-493a-ae0b-dbb606d7a41d 61 fields · synced May 17, 2026
- EUDAMED e7e42ebc-dca2-418a-bf3c-c387a1c21211 61 fields · synced May 17, 2026
- EUDAMED a685c3e5-a34d-4ca2-b071-5c8d1c74fb39 61 fields · synced May 17, 2026
- EUDAMED 835b5436-1388-4059-a3df-336a6bc5e7ab 61 fields · synced May 17, 2026
- EUDAMED eec0cb58-a9f2-461c-8f06-2b0d585a5563 61 fields · synced May 17, 2026
- EUDAMED 5b97beb2-3509-4b65-b465-2aad251a6d28 61 fields · synced May 17, 2026
- EUDAMED 0702c4f1-71f3-4e16-bd46-b4acb46ddca2 61 fields · synced May 17, 2026
- EUDAMED 6729b271-17e6-4ccd-bb15-9f9aea9270b7 61 fields · synced May 17, 2026
- EUDAMED 6fc1866d-62d3-42d2-9171-d1146df945f0 61 fields · synced May 17, 2026
- EUDAMED 7df98332-a729-4126-996a-d0d1620c8b8e 61 fields · synced May 18, 2026
- EUDAMED 45f2c0e1-f176-4548-baa0-d1d407a658d3 61 fields · synced May 18, 2026
- EUDAMED dd1c92a9-c033-4865-8f26-256bb98f1220 61 fields · synced May 18, 2026
- FDA UDI 0497bd6e-4038-4f33-a1f6-8b9d7e17c1f7 36 fields · synced May 29, 2026