Identity
- Trade Name
- Leica 818 EUDAMED
- Device Name
- Leica DB80 HS, LS, LX; 818, 819 EUDAMED
- Model / Reference
- 14035838926 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04049188114587 EUDAMED
- Basic UDI-DI
- 010404918803589W EUDAMED
- EMDN Code
- V010302 BLADES WITHOUT SAFETY SYSTEMS, SINGLE-USE - NOT INCLUDED IN OTHER CLASSES EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Category: Manual scalpel blade, single-use
Leica 818 by Leica Biosystems Nussloch Gmbh — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 010404918803589W | Class A | Active |
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Manufacturer
- Manufacturer
- Leica Biosystems Nussloch GmbH
- EUDAMED SRN
- DE-MF-000021943
Sources (1)
- EUDAMED 313e47d2-7880-4b5a-b568-807edad0bde4 61 fields · synced Jul 23, 2026