Identity
- Trade Name
- Neoflex EUDAMEDFDA UDI
- Generic Name
- External lower-limb prosthesis suspensory component, non-powered FDA UDI
- Device Name
- Neoflex EUDAMEDProsthetic suspension sleeve with knee pad reinforcement in gray color and size 4.0. FDA UDI
- Model / Reference
- CA700-FP-T0 EUDAMEDCA700-FP-G4 EUDAMEDFDA UDI
- Description
- Prosthetic suspension sleeve with knee pad reinforcement in gray color and size 4.0. FDA UDI
Identifiers
- Catalog Number
- CA700-FP-G4 FDA UDI
- Primary DI / UDI-DI
- 00850013242672 EUDAMEDFDA UDI
- Basic UDI-DI
- 850013242SLEEVESE3 EUDAMED
- FDA Product Code
- ISS 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
Neoflex 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 | 850013242SLEEVESE3 | 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 ebff0214-f1a8-41d5-a4b7-4a81711ced4f 61 fields · synced Jun 19, 2026
- FDA UDI dace00c0-96d6-4203-91a0-5a97c62590d0 34 fields · synced May 30, 2026