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Zephyr Patient Positioning and Transfer System
EUDAMEDFDA UDIClass I (EU MDR)
Ref ZTG-AIX-01
by Diacor Inc.
Identity
- Trade Name
- Zephyr Patient Positioning and Transfer System EUDAMEDZephyr Patient Stretcher FDA UDI
- Generic Name
- Hospital stretcher, manual FDA UDI
- Device Name
- Zephyr Patient Stretchers & Accessories EUDAMEDZephyr Procedural Stretcher Accessory - Stretcher Indexing. Includes removable side stops and floor indexing kits. (ZTG-AIX-02 also required) FDA UDI
- Model / Reference
- ZTG-AIX-01 EUDAMEDFDA UDI
- Description
- Zephyr Procedural Stretcher Accessory - Stretcher Indexing. Includes removable side stops and floor indexing kits. (ZTG-AIX-02 also required) FDA UDI
Identifiers
- Primary DI / UDI-DI
- B237ZTGAIX010 EUDAMEDFDA UDI
- Basic UDI-DI
- ++B237STRETCHERRL EUDAMED
- FDA Product Code
- FPO FDA UDI
- EMDN Code
- V08050101 GENERIC USE STRETCHERS EUDAMED
- GMDN Term
- Hospital stretcher, manual FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 880.6910 FDA UDI
- Market of Registration
- Germany 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
Yes
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
Zephyr Patient Positioning and Transfer System by Diacor Inc. — 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 | ++B237STRETCHERRL | 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 a664f567-07cc-4f3b-85e5-f430528482ba 61 fields · synced Jul 31, 2026
- FDA UDI 51a1374b-2bcf-4f47-8cf3-8fb1bce99769 33 fields · synced May 30, 2026