Identity
- Trade Name
- Dornier Thulio EUDAMEDFDA UDI
- Generic Name
- General/multiple surgical solid-state laser system FDA UDI
- Device Name
- Dornier Thulio EUDAMEDFDA UDI
- Model / Reference
- K2016000 EUDAMEDFDA UDI
- Description
- Dornier Thulio FDA UDI
Identifiers
- Catalog Number
- K2016000 FDA UDI
- Primary DI / UDI-DI
- 04049958004551 EUDAMEDFDA UDI
- Basic UDI-DI
- 4049958DornierThulioF8 EUDAMED
- FDA Product Code
- GEX FDA UDI
- EMDN Code
- Z12011006 DIODE–PUMPED SOLID–STATE (DPSS) SURGICAL LASER EUDAMED
- GMDN Term
- General/multiple surgical solid-state laser 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
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
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 Thulio by Dornier Medtech Gmbh — Class IIb — 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 | 4049958DornierThulioF8 | 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 f758df62-5431-42cb-990e-d11b9ce22ea9 61 fields · synced Jul 14, 2026
- FDA UDI fde54a17-79aa-4fa4-97bb-fb750f2966e8 34 fields · synced May 30, 2026