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Patient Interface Device
EUDAMEDClass IIb (EU MDR)
Ref 70-00036-001Model 70-00050-001
by Lensar
Identity
- Trade Name
- Patient Interface Device EUDAMED
- Device Name
- ALLY Adaptive Cataract Treatment System EUDAMED
- Model / Reference
- 70-00050-001 EUDAMED70-00036-001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850062486027 EUDAMED
- Basic UDI-DI
- 08677440001ALLYUN EUDAMED
- Direct Marketing DI
- 00850062486027 EUDAMED
- EMDN Code
- Z12120285 THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - CONSUMABLES EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
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
Patient Interface Device by Lensar — 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 | 08677440001ALLYUN | Class IIb | Active |
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Manufacturer
- Manufacturer
- Lensar
- EUDAMED SRN
- US-MF-000008522
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 4d30c3dd-53d3-4a8d-8cfa-426be833434b 61 fields · synced Jun 18, 2026