Identity
- Model / Reference
- ZMT400 EUDAMEDZMT400I175 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-USMF0000389680012576N EUDAMED
- Basic UDI-DI
- B-USMF0000389680012576N EUDAMED
- EMDN Code
- P030102100301 IOLs, APHAKIC, MULTIFOCAL, TORIC, HYDROPHOBIC ACRYLIC EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
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
Zmt400i175 by Johnson & Johnson Surgical Vision, Inc. — Class IIb — 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-USMF0000389680012576N | Class IIb | Active |
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Manufacturer
- Manufacturer
- Johnson & Johnson Surgical Vision, Inc.
- EUDAMED SRN
- US-MF-000038968
- Authorised Representative
- AMO Ireland IE-AR-000013513
Sources (1)
- EUDAMED 72fc9b2e-9842-41b3-a644-66a71ff32ad3 61 fields · synced Jun 18, 2026