Identity
- Device Name
- Test Chamber (2 PCS) EUDAMED
- Model / Reference
- 116001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08059308000801 EUDAMED
- Basic UDI-DI
- 8059308SUR_ACC_009JP EUDAMED
- EMDN Code
- Q020680 PHACOEMULSIFICATION DEVICES - ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
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
Test Chamber (2 PCS) by Optikon 2000 S.p.A. — Class I — 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 | 8059308SUR_ACC_009JP | Class I | Active |
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Manufacturer
- Manufacturer
- Optikon 2000 S.p.A.
- EUDAMED SRN
- IT-MF-000017618
Sources (1)
- EUDAMED f952ffe7-0593-4a5e-ab53-40c7866c5450 61 fields · synced Jul 12, 2026