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Stainless steel barb - straight
EUDAMEDFDA UDIClass I (EU MDR)
Ref CA300-BSTModel CA100-AK
Identity
- Trade Name
- Stainless steel barb - straight EUDAMEDStainless steel barb straight FDA UDI
- Generic Name
- External lower-limb prosthesis suspensory component, non-powered FDA UDI
- Device Name
- Aria Valve AK (above knee) EUDAMEDStainless steel barb straight for installation into prosthetic sockets FDA UDI
- Model / Reference
- CA100-AK EUDAMEDCA300-BST EUDAMEDFDA UDI
- Description
- Stainless steel barb straight for installation into prosthetic sockets FDA UDI
Identifiers
- Catalog Number
- CA300-BST FDA UDI
- Primary DI / UDI-DI
- 00850013242269 EUDAMEDFDA UDI
- Basic UDI-DI
- 850013242VALVES74 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
- Netherlands 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
Stainless steel barb - straight 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 | 850013242VALVES74 | 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 85a95736-ea19-4d76-bd27-60feb1fe0bda 61 fields · synced Jul 9, 2026
- FDA UDI 438d7971-b582-43f6-83f7-41a1ae2753fc 34 fields · synced May 30, 2026