Identity
- Trade Name
- Neo + EUDAMEDJenx (Daytot) FDA UDI
- Generic Name
- Patient positioning vacuum mattress FDA UDI
- Device Name
- Patient positioning vacuum mattress EUDAMEDNeo+ Kit FDA UDI
- Model / Reference
- 208-600 EUDAMEDFDA UDI
- Description
- Neo+ Kit FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05056235223337 EUDAMEDFDA UDI
- Basic UDI-DI
- 50562352POSVACCUSHIOND8 EUDAMED
- FDA Product Code
- CCX FDA UDI
- EMDN Code
- Y180999 CHAIRS / POSTURE SYSTEMS / SEAT POSITIONING AIDS - OTHER EUDAMED
- GMDN Term
- Patient positioning vacuum mattress FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 868.6820 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: Patient positioning vacuum mattress
Jenx (Daytot) by Jenx Limited — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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- Jenx (Daytot) — JENX LIMITED · Class I
- Jenx (Daytot) — JENX LIMITED · Class I
- Jenx (Daytot) — JENX LIMITED · Class I
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 f88d7dbc-ef5d-40b6-bd5c-299da64b204c 33 fields · synced Jun 19, 2026
- EUDAMED 2f766edd-3aae-44b6-bbb9-2a186e6cc588 61 fields · synced Jun 19, 2026