Identity
- Trade Name
- Diacor Overlays EUDAMEDDiacor Overlay FDA UDI
- Generic Name
- Radiological whole-body positioner FDA UDI
- Device Name
- Flat Table Tops & Accessories EUDAMEDZephyr MR FTT for GE MR GEM Cart FDA UDI
- Model / Reference
- ZXL-TGE-20 EUDAMEDFDA UDI
- Description
- Zephyr MR FTT for GE MR GEM Cart FDA UDI
Identifiers
- Primary DI / UDI-DI
- B237ZXLTGE200 EUDAMEDFDA UDI
- Basic UDI-DI
- ++B237FTTRC EUDAMED
- Direct Marketing DI
- B237ZXLTGE200 EUDAMED
- FDA Product Code
- IXQ FDA UDI
- EMDN Code
- V0804 PATIENT IMMOBILISERS (in diagnostic or therapeutic procedures) EUDAMED
- GMDN Term
- Radiological whole-body positioner FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1980 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Safe FDA UDI
Diacor Overlays 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 | ++B237FTTRC | 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 c100c88f-88b9-42f5-adee-64ce0bf6b3ff 61 fields · synced May 30, 2026
- FDA UDI 492ce323-1f51-4f73-b803-ec2c13162573 34 fields · synced May 30, 2026