Identity
- Trade Name
- Dornier HRM EUDAMEDDornier MedTech FDA UDI
- Generic Name
- Laser lithotripsy system FDA UDI
- Device Name
- Dornier Medilas H UroPulse EUDAMEDMedilas HRM UroPulse Holmium Laser with wired footswitch FDA UDI
- Model / Reference
- K2012900 EUDAMEDMedilas HRM Laser FDA UDI
- Description
- Medilas HRM UroPulse Holmium Laser with wired footswitch FDA UDI
Identifiers
- Catalog Number
- K2012900 FDA UDI
- Primary DI / UDI-DI
- 04049958002625 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04049958002625 EUDAMED
- FDA Product Code
- GEX FDA UDI
- EMDN Code
- Z12011003 HOLMIUM SURGICAL LASER EUDAMED
- GMDN Term
- Laser lithotripsy system FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4810 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
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
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 HRM 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-04049958002625 | 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 74f82f7a-093f-4014-8a9a-c40f189324bc 61 fields · synced Jun 18, 2026
- FDA UDI 48cd8d96-257c-4eea-984f-35a824852f3c 34 fields · synced May 30, 2026