Identity
- Model / Reference
- 590106AN EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-USMF000023322000007N7 EUDAMED
- Basic UDI-DI
- B-USMF000023322000007N7 EUDAMED
- EMDN Code
- Z12120285 THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - CONSUMABLES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Ireland 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
590106an by AMO Manufacturing USA, LLC — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-USMF000023322000007N7 | Class IIa | Active |
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Manufacturer
- Manufacturer
- AMO Manufacturing USA, LLC
- EUDAMED SRN
- US-MF-000023322
- Authorised Representative
- AMO Ireland IE-AR-000013513
Sources (1)
- EUDAMED aaa2697f-b76d-474b-86ba-7a37ff1fda09 61 fields · synced Jul 31, 2026