Zephyr Patient Positioning and Transfer System
EUDAMEDFDA UDIClass I (EU MDR)
by Diacor Inc.
Identity
- Trade Name
- Zephyr Patient Positioning and Transfer System EUDAMEDFDA UDI
- Generic Name
- Radiological whole-body positioner FDA UDI
- Device Name
- Zephyr Hoverboards & Accessories EUDAMEDZephyr IR-S Collision Indicators for GE Premier Fixed Couch FDA UDI
- Model / Reference
- ZXL-ACI-13 EUDAMEDFDA UDI
- Description
- Zephyr IR-S Collision Indicators for GE Premier Fixed Couch FDA UDI
Identifiers
- Primary DI / UDI-DI
- B237ZXLZCI130 EUDAMEDB237ZXLACI130 FDA UDI
- Basic UDI-DI
- ++B237HOVERBOARDV7 EUDAMED
- 510(k) Number
- K121929 FDA UDI
- FDA Product Code
- LNH FDA UDI
- EMDN Code
- V080504 PATIENT TRANSFER BOARDS AND TABLES EUDAMED
- GMDN Term
- Radiological whole-body positioner FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1000 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
No
Category: Patient lifting system stretcher
Zephyr Patient Positioning and Transfer System by Diacor Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++B237HOVERBOARDV7 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Diacor Inc.
- EUDAMED SRN
- US-MF-000017181
- Authorised Representative
- E C REP LIMITED IE-AR-000003995
Sources (2)
- EUDAMED 0949fd46-49ce-496f-a6d5-2817a2ecdba6 61 fields · synced Jul 13, 2026
- FDA UDI 76e50e12-4eb8-4bc9-9e9e-63df2e5a3a22 35 fields · synced May 30, 2026