Identity
- Trade Name
- Dornier Delta III FDA UDI
- Generic Name
- Electromechanical lithotripsy system, extracorporeal FDA UDI
- Device Name
- Dornier Delta III Pro - DELTA III PRO XRAY 15KW/SW E180 DMT-A FDA UDI
- Model / Reference
- K1045938 FDA UDI
- Description
- Dornier Delta III Pro - DELTA III PRO XRAY 15KW/SW E180 DMT-A FDA UDI
Identifiers
- Catalog Number
- K1045938 FDA UDI
- Primary DI / UDI-DI
- 04049957006471 FDA UDI
- FDA Product Code
- LNS FDA UDI
- GMDN Term
- Electromechanical lithotripsy system, extracorporeal FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5990 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Electromechanical lithotripsy system, extracorporeal
Dornier Delta III by Dornier MedTech GmbH — Class II — MDR, MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Electromechanical lithotripsy system, extracorporeal.
- MODULITH® — Storz Medical AG · Class II
- Modularis Variostar — Siemens Healthcare · Class II
- INTEGRA — Direx Systems Corp. · Class II
- DUET MAGNA — Direx Systems Corp. · Class II
- Extracorporeal Shock Wave Lithotripter — Suzhou Xixin Medical Instruments Co., Ltd. · Class II
- Econolith EM1000 — Medispec, Ltd. · Class II
- MODULITH® — Storz Medical AG · Class II
- Econolith EM1000 — Medispec, Ltd. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Dornier MedTech GmbH
Sources (2)
- FDA UDI 83adcc8e-584b-4caf-8907-748bf83b7c49 34 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 3, 2026