Identity
- Trade Name
- X-Ray Top Set TS 7000 EUDAMEDX-Ray Top Head Section FDA UDI
- Generic Name
- Universal operating table top FDA UDI
- Device Name
- Zubehör & Accessories EUDAMED
- Model / Reference
- 6124-04-00-00 EUDAMED6124-04-01-00 FDA UDI
Identifiers
- Catalog Number
- 2085445 FDA UDI
- Primary DI / UDI-DI
- 04251732800284 EUDAMEDFDA UDI
- Basic UDI-DI
- 42517328ACCRS EUDAMED
- Direct Marketing DI
- 04251732800284 EUDAMED
- FDA Product Code
- JEB FDA UDI
- EMDN Code
- Z12011280,Z12011299 EUDAMED
- GMDN Term
- Universal operating table top FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4950 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
X-Ray Top Set TS 7000 by Jörg & Sohn 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 | 42517328ACCRS | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Jörg & Sohn GmbH
- EUDAMED SRN
- DE-MF-000011346
Sources (2)
- EUDAMED abb1278a-8575-4a61-98d4-d0c0e401e86b 61 fields · synced Jun 19, 2026
- FDA UDI 1c833275-a943-458f-99b5-d3c39e22c5dc 33 fields · synced May 30, 2026