Identity
- Trade Name
- DORADOnova MR3T bridge EUDAMEDDORADO FDA UDI
- Generic Name
- Laser patient positioning system FDA UDI
- Device Name
- Laser patient positioning system EUDAMED
- Model / Reference
- 0013821 EUDAMEDDORADOnova MR3T FDA UDI
Identifiers
- Catalog Number
- 0013821 FDA UDI
- Primary DI / UDI-DI
- 04260590370563 EUDAMEDFDA UDI
- Basic UDI-DI
- 426059037PATPOSLASERCR EUDAMED
- FDA Product Code
- IYE FDA UDI
- EMDN Code
- Z119010 LASER SYSTEMS FOR PATIENT POSITIONING EUDAMED
- GMDN Term
- Laser patient positioning system FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.5050 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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Category: Laser patient positioning system
Dorado by L A P Gmbh Laser Applikationen — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- L A P Gmbh Laser Applikationen
Sources (2)
- FDA UDI 37020236-9132-424c-b05a-6113aae9041b 33 fields · synced Jun 18, 2026
- EUDAMED df8ea889-d050-4d11-8fef-d9d54eba0dad 61 fields · synced Jun 18, 2026