Identity
- Trade Name
- DELTA EUDAMEDFDA UDI
- Generic Name
- Diagnostic x-ray system generator, stationary FDA UDI
- Device Name
- High Voltage Generator DMP-100R EUDAMED
- Model / Reference
- DMG-50KAX B EUDAMEDFDA UDIDMG-50KAX BC EUDAMED
Identifiers
- Catalog Number
- DMP-100R FDA UDI
- Primary DI / UDI-DI
- 04718018530025 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04718018530025 EUDAMED
- FDA Product Code
- IZO FDA UDI
- EMDN Code
- Z11039011 HIGH VOLTAGE X-RAY GENERATORS EUDAMED
- GMDN Term
- Diagnostic x-ray system generator, stationary FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass I FDA UDI
- Regulation Number
- 892.1700 FDA UDI
- Market of Registration
- Türkiye 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Diagnostic x-ray system generator, stationary
Delta by Delta Electronics, Inc. — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Diagnostic x-ray system generator, stationary.
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04718018530025 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Delta Electronics, Inc.
- EUDAMED SRN
- TW-MF-000003930
- Authorised Representative
- Delta Electronics (Netherlands) B.V. NL-AR-000001692
Sources (2)
- EUDAMED f226ab78-07c2-4f1e-8507-8a2a760f5044 61 fields · synced Jul 14, 2026
- FDA UDI 9a1d6bf0-3205-4f8b-8129-fdc101486c86 33 fields · synced May 26, 2026