Identity
- Model / Reference
- ZCT100 EUDAMEDZCT1000260 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-USMF0000389680004486Q EUDAMED
- Basic UDI-DI
- B-USMF0000389680004486Q EUDAMED
- EMDN Code
- P030102090301 IOLs, APHAKIC, MONOFOCAL, 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
Zct1000260 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-USMF0000389680004486Q | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Johnson & Johnson Surgical Vision, Inc.
- EUDAMED SRN
- US-MF-000038968
- Authorised Representative
- AMO Ireland IE-AR-000013513
Sources (1)
- EUDAMED 041f8f58-7161-4b98-ad75-e082b9455031 61 fields · synced Jun 19, 2026