Identity
- Trade Name
- Dornier MedTech FDA UDI
- Generic Name
- Electromechanical lithotripsy system, extracorporeal FDA UDI
- Device Name
- Dornier Compact Sigma EUDAMEDCompact Sigma Lithotripter, 220V, 60 Hz FDA UDI
- Model / Reference
- K1029396 EUDAMEDCompact Sigma FDA UDI
- Description
- Compact Sigma Lithotripter, 220V, 60 Hz FDA UDI
Identifiers
- Catalog Number
- K1029396 FDA UDI
- Primary DI / UDI-DI
- 04049957000028 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04049957000028 EUDAMED
- 510(k) Number
- K002929 FDA UDI
- FDA Product Code
- LNS FDA UDI
- EMDN Code
- Z12020301 ELECTROMECHANICAL ENDOSCOPIC LITHOTRIPTERS EUDAMED
- GMDN Term
- Electromechanical lithotripsy system, extracorporeal FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 876.5990 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
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
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
Dornier Compact Sigma by Dornier Medtech Gmbh — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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-04049957000028 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Dornier MedTech GmbH
- EUDAMED SRN
- DE-MF-000009774
Sources (2)
- EUDAMED 66272064-e72f-4f9f-b133-d31da3fe5a3f 61 fields · synced Jul 9, 2026
- FDA UDI 69aa08e0-bf95-4873-8aa5-bc77e01ecd51 35 fields · synced May 30, 2026