Identity
- Trade Name
- PROGNOST XPE-Akku EUDAMEDFDA UDI
- Generic Name
- Basic diagnostic x-ray system table, powered FDA UDI
- Device Name
- PROGNOST XPE-Akku EUDAMEDBasic diagnostic x-ray system table, powered FDA UDI
- Model / Reference
- 7038-9-1712 EUDAMEDtable top 226x75,5cm composite fiber FDA UDI
- Description
- Basic diagnostic x-ray system table, powered FDA UDI
Identifiers
- Catalog Number
- 7038-9-1712 FDA UDI
- Primary DI / UDI-DI
- 04260502640326 EUDAMEDFDA UDI
- Basic UDI-DI
- 426050264X024ZP EUDAMED
- FDA Product Code
- KXJ FDA UDI
- EMDN Code
- Z11030503 PATIENT TABLES FOR RADIOLOGICAL EQUIPMENT EUDAMED
- GMDN Term
- Basic diagnostic x-ray system table, powered 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
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
PROGNOST XPE-Akku by PROTEC X-ray Systems GmbH — 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 | 426050264X024ZP | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- PROTEC X-ray Systems GmbH
- EUDAMED SRN
- DE-MF-000048351
Sources (2)
- EUDAMED 4194593c-4360-4acf-845a-f75522513e16 61 fields · synced Jul 11, 2026
- FDA UDI cb7ae3b3-808a-4ee6-8e90-15507c5ed7cd 35 fields · synced May 30, 2026