Identity
- Trade Name
- Atom Simple Footplate White/Blue EUDAMEDJenx FDA UDI
- Generic Name
- Footrest FDA UDI
- Device Name
- Accessories EUDAMEDAtom Simple Footplate White/Blue FDA UDI
- Model / Reference
- AT01 009-08-01 EUDAMEDFDA UDI
- Description
- Atom Simple Footplate White/Blue FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05056235209195 EUDAMEDFDA UDI
- Basic UDI-DI
- 50562352POSTURESYSACC4F EUDAMED
- FDA Product Code
- INN FDA UDI
- EMDN Code
- Y180980 SEATING SYSTEMS / POSTURE SYSTEMS / SEATING AIDS - ACCESSORIES EUDAMED
- GMDN Term
- Footrest FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.3100 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
Yes
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
Yes
FDA UDI
Category: Footrest
Jenx by Jenx Limited — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Jenx Limited
Sources (2)
- FDA UDI 897c8774-411e-42f0-851a-e1a31b6331de 33 fields · synced Jul 31, 2026
- EUDAMED 29c0fe0d-12fc-49b2-8e22-45a4e3f3d26f 61 fields · synced Jul 31, 2026