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AQUARIUZ corneal ablation laser
EUDAMEDClass IIb (EU MDR)
Ref 610.001.001Model AQUARIUZ corneal ablation laser
Identity
- Trade Name
- AQUARIUZ corneal ablation laser EUDAMED
- Device Name
- AQUARIUZ corneal ablation laser EUDAMED
- Model / Reference
- AQUARIUZ corneal ablation laser EUDAMED610.001.001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07640167751396 EUDAMED
- Basic UDI-DI
- 764016775ABLXXXFZ EUDAMED
- EMDN Code
- Q020199 OPHTHALMIC CUTTING DEVICES - OTHER 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
AQUARIUZ corneal ablation laser by SMT Swiss Microtechnology AG — 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 | 764016775ABLXXXFZ | Class IIb | Active |
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Manufacturer
- Manufacturer
- SMT Swiss Microtechnology AG
- EUDAMED SRN
- CH-MF-000025016
- Authorised Representative
- Ziemer Ophthalmology (DE) GmbH DE-AR-000005638
Sources (1)
- EUDAMED 94387c84-7e71-43f4-8d5d-455a2fa0f2d2 61 fields · synced Jul 11, 2026