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IOPtimate
EUDAMEDClass IIb (EU MDR)
Ref ASS‐35‐102Model OT-135P2
by IOPtima Ltd.
Identity
- Trade Name
- IOPtimate EUDAMED
- Device Name
- IOPtimate EUDAMED
- Model / Reference
- OT-135P2 EUDAMEDASS‐35‐102 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07290014930001 EUDAMED
- Basic UDI-DI
- B-07290014930001 EUDAMED
- EMDN Code
- Q0299 OPHTHALMIC DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
IOPtimate by IOPtima Ltd. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union No Longer Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-07290014930001 | Class IIb | No Longer Active |
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Manufacturer
- Manufacturer
- IOPtima Ltd.
- EUDAMED SRN
- IL-MF-000020552
- Authorised Representative
- MedNet EC-REP IIb GmbH DE-AR-000011192
Sources (1)
- EUDAMED 3fbb6c0d-5fe1-47c4-a562-46be256dc899 61 fields · synced Jun 18, 2026