Identity
- Trade Name
- Opsil - Standard EUDAMED
- Device Name
- Opsil-Standard EUDAMEDOpSil EUDAMED
- Model / Reference
- M901 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060483010144 EUDAMED
- Basic UDI-DI
- 506048301TF2D7 EUDAMED
- Direct Marketing DI
- 05060483010144 EUDAMED
- EMDN Code
- Q0299 OPHTHALMIC DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Malta 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
Opsil-Standard by Technovent Limited — 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 | 506048301TF2D7 | Class I | Active |
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Manufacturer
- Manufacturer
- Technovent Limited
- EUDAMED SRN
- GB-MF-000006738
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED 62b61283-3897-41aa-a818-7bc5ae7fbd65 61 fields · synced Jun 18, 2026
- EUDAMED c1c5855e-0368-4a9e-9bbe-4bca8c16feb7 61 fields · synced Jun 18, 2026