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Staxi
EUDAMEDFDA UDIClass I (EU MDR)
Ref MR010-TModel Staxi Guest Services Chair
by Staxi Corp.
Identity
- Trade Name
- Staxi EUDAMEDFDA UDI
- Generic Name
- Wheelchair, attendant-driven, non-collapsible FDA UDI
- Device Name
- Guest Services Chair EUDAMEDStaxi MRI Chair Color: Teal FDA UDI
- Model / Reference
- Staxi Guest Services Chair EUDAMEDMR010-T EUDAMEDFDA UDI
- Description
- Staxi MRI Chair Color: Teal FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850039103063 EUDAMEDFDA UDI
- Basic UDI-DI
- 850039103Staxi.CHR.A52 EUDAMED
- Direct Marketing DI
- 00850039103063 EUDAMED
- FDA Product Code
- INN FDA UDI
- EMDN Code
- Y122103 PUSH WHEELCHAIRS EUDAMED
- GMDN Term
- Wheelchair, attendant-driven, non-collapsible FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.3100 FDA UDI
- Market of Registration
- Ireland 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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Staxi by Staxi Corp. — 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 | 850039103Staxi.CHR.A52 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Staxi Corp.
- EUDAMED SRN
- US-MF-000050389
- Authorised Representative
- MedEnvoy Global BV NL-AR-000024028
Sources (2)
- EUDAMED 701e29a3-7127-4b85-839e-a01bfbc62dba 61 fields · synced Jul 8, 2026
- FDA UDI c1188217-9ea7-45d8-9a00-a0f14f003795 33 fields · synced May 30, 2026