Identity
- Trade Name
- Standz 2 Flexi Laterals Support Pad Cover Pair Pink EUDAMEDJenx FDA UDI
- Generic Name
- Medical cushion cover FDA UDI
- Device Name
- Accessories EUDAMEDStandz 2 Flexi Laterals Support Pad Cover Pair Pink FDA UDI
- Model / Reference
- COVSTZ06-02 EUDAMEDFDA UDI
- Description
- Standz 2 Flexi Laterals Support Pad Cover Pair Pink FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05056235220442 EUDAMEDFDA UDI
- Basic UDI-DI
- 50562352POSTURESYSACC4F EUDAMED
- FDA Product Code
- INW FDA UDI
- EMDN Code
- Y180980 SEATING SYSTEMS / POSTURE SYSTEMS / SEATING AIDS - ACCESSORIES EUDAMED
- GMDN Term
- Medical cushion cover FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.3750 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: Medical cushion cover
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 c6aaee51-05f9-4e3e-92c7-0077ac99f279 33 fields · synced Jul 13, 2026
- EUDAMED 6db59776-f2bc-4acd-b4b8-c47fa7b11d8d 61 fields · synced Jul 13, 2026