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Schwind Amaris 500e
EUDAMEDClass IIb (EU MDR)
Ref 16800Model SCHWIND AMARIS 500E
Identity
- Trade Name
- SCHWIND AMARIS 500E EUDAMED
- Device Name
- SCHWIND AMARIS EUDAMED
- Model / Reference
- SCHWIND AMARIS 500E EUDAMED16800 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260157140219 EUDAMED
- Basic UDI-DI
- 426015714E057-EXCIMER6M EUDAMED
- EMDN Code
- Z12011001 EXCIMER SURGICAL LASER EUDAMED
Classification
- Device Class
- Class IIb 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
Schwind Amaris 500e by SCHWIND eye-tech-solutions GmbH — Class IIb — 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 | 426015714E057-EXCIMER6M | Class IIb | Active |
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Manufacturer
- Manufacturer
- SCHWIND eye-tech-solutions GmbH
- EUDAMED SRN
- DE-MF-000019049
Sources (2)
- EUDAMED c415c444-22d7-4fcc-a84e-b8020dd92ff8 61 fields · synced Jun 19, 2026
- EUDAMED fe0c3420-4fda-40ec-885b-757df16139d2 61 fields · synced Jun 19, 2026