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FL400 for M530
EUDAMEDFDA 510(k)Class I (EU MDR)
Ref 10449183Model FL400 for M530
Identity
- Trade Name
- FL400 for M530 EUDAMED
- Device Name
- FL400 for M530 EUDAMED
- Model / Reference
- FL400 for M530 EUDAMED10449183 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07630802403414 EUDAMED
- Basic UDI-DI
- 76308024FL400C4 EUDAMED
- EMDN Code
- Z12011199 INSTRUMENTS FOR OPERATIVE MICROSCOPY – OTHER 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
FL400 for M530 by Leica Microsystems (schweiz) Ag — Class I — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | DEN180024 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 76308024FL400C4 | Class I | Active |
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Manufacturer
- Manufacturer
- Leica Microsystems (Schweiz) AG
- EUDAMED SRN
- CH-MF-000021185
- Authorised Representative
- Leica Microsystems CMS GmbH DE-AR-000021052
Sources (2)
- EUDAMED 47fe5634-ecf7-4a0f-b6b3-96de1fd53c74 61 fields · synced Jun 20, 2026
- FDA 510(k) DEN180024 1 fields · synced May 18, 2026