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Aria Universal mini valve tool
EUDAMEDFDA UDIClass I (EU MDR)
Ref CA100-MVKModel CA100-K
Identity
- Trade Name
- Aria Universal mini valve tool EUDAMEDAria Universal Mini Valve Key FDA UDI
- Generic Name
- External lower-limb prosthesis suspensory component, non-powered FDA UDI
- Device Name
- Aria Valve AK - Valve Key EUDAMEDTool to install or remove valves for prosthesis sockets FDA UDI
- Model / Reference
- CA100-K EUDAMEDCA100-MVK EUDAMEDFDA UDI
- Description
- Tool to install or remove valves for prosthesis sockets FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850013242887 EUDAMEDFDA UDI
- Basic UDI-DI
- 850013242TOOLS8X EUDAMED
- FDA Product Code
- ISP FDA UDI
- EMDN Code
- Y99 DEVICES FOR PERSONS WITH DISABILITIES NOT INCLUDED IN OTHER CATEGORIES - OTHER EUDAMED
- GMDN Term
- External lower-limb prosthesis suspensory component, non-powered FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.3420 FDA UDI
- Market of Registration
- France 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Aria Universal mini valve tool by Cypress Adaptive, Llc — 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 | 850013242TOOLS8X | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Cypress Adaptive LLC
- EUDAMED SRN
- US-MF-000016964
- Authorised Representative
- Romedis GmbH DE-AR-000037131
Sources (2)
- EUDAMED bfc0e017-f68b-4562-947e-1b572a972f4b 61 fields · synced Jul 21, 2026
- FDA UDI e0ac7eed-3d55-4510-84ee-7f172d87b2dc 33 fields · synced May 30, 2026