Identity
- Trade Name
- Atom seat with grey sides (yellow) EUDAMEDJenx FDA UDI
- Generic Name
- Assistive ergonomic chair, manually-adjusted FDA UDI
- Device Name
- Assistive ergonomic chair, manually-adjusted EUDAMEDAtom Seat Unit With Grey Sides Yellow FDA UDI
- Model / Reference
- AT01-05-09 EUDAMEDFDA UDI
- Description
- Atom Seat Unit With Grey Sides Yellow FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05056235200062 EUDAMEDFDA UDI
- Basic UDI-DI
- 50562352ASSISTERGCHAIRDP EUDAMED
- FDA Product Code
- INN FDA UDI
- EMDN Code
- Y180939 MODULAR POSTURE SYSTEMS EUDAMED
- GMDN Term
- Assistive ergonomic chair, manually-adjusted 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Assistive ergonomic chair, manually-adjusted
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 145c8ac6-5e58-4a82-9cfd-9d9aef04a143 33 fields · synced Jul 17, 2026
- EUDAMED b9c19d5b-907a-4b4a-88f1-39ccbe058a64 61 fields · synced Jul 17, 2026