Identity
- Trade Name
- LIT2-D-HAN EUDAMED
- Device Name
- LIT-Handle EUDAMED
- Model / Reference
- 70100146616 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04044503005564 EUDAMED
- Basic UDI-DI
- 40445030563244 EUDAMED
- Direct Marketing DI
- 04044503005564 EUDAMED
- EMDN Code
- G030502 LITHOTRIPSY DEVICES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Lit2-D-Han by FUJIFILM medwork GmbH — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 40445030563244 | Class I | Active |
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Manufacturer
- Manufacturer
- FUJIFILM medwork GmbH
- EUDAMED SRN
- DE-MF-000008444
Sources (1)
- EUDAMED 11a3b7ee-737b-4a15-bfbb-0c8b2f7c33c0 61 fields · synced Jun 18, 2026